As part of an academic medical center, the Division of Cardiology within the Department of Medicine at Northwestern University Feinberg School of Medicine (Feinberg) aims to improve the human health through scientific research.
About Clinical Trials
Clinical trials test or study drugs, surgical procedures, medical devices, or interventions with human subjects. They look to determine their safety and effectiveness in relation to treating specific diseases. Clinical trials are part of clinical research and are at the heart of all medical advances.
Division of Cardiology, Department of Medicine
The following searchable list includes all the Division of Cardiology, Department of Medicine clinical trials currently looking for participants.
Please feel free to contact us with inquiries about any of our ongoing research.
Non-invasive Detection of Right Ventricular Interstitial Fibrosis using MRI in Patients with Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction
This study seeks to explore the structural alterations in the right ventricle (RV) of patients with heart failure with preserved ej…
This study seeks to explore the structural alterations in the right ventricle (RV) of patients with heart failure with preserved ejection fraction (HFpEF) by employing cardiac MRI-derived T1 mapping, an indicator of the degree of diffuse fibrosis, that may allow us to answer the following research questions: 1) Does T1 mapping accurately detect diffuse RV fibrosis?; 2) Do pulmonary hypertension (PH) HFpEF patients have increased RV fibrosis compared to controls and/or HFpEF patients without PH?; 3) Does the amount of RV fibrosis correlate with the degree of RV dysfunction?; 4) Does the degree of RV fibrosis vary between various etiologies of PH? Given NMHC's unique and robust HFpEF program and strength in cardiovascular MR research, Northwestern is uniquely suited for this endeavor. The ultimate goal is to provide mechanistic insight into these conditions so that effective, targeted therapies can be developed.
HFN - CHART
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy. We will evaluate how well your heart is working and measure proteins and chemicals in your blood. This study consists of a serie…
The purpose of this study is to better understand how the heart’s health and function is affected by HIV infection and use of active antiretroviral therapy. We will evaluate how well your heart is working and measure proteins and chemicals in your blood. This study consists of a series of tests that may be completed in one visit or may be divided between two or more visits. We expect up to 20 people here will be in this research study out of approximately 200 people in the entire study nationally.
Age >40 years
Willingness and ability to provide informed consent
HIV antibody positive
On HAART for >6 months (HIV positive cohort only)
History of adequate viral suppression as defined by HIV RNA level <200 copies/mL in the past 6 months
LVEF >50% -
Past EF <50%
Moderate or severe valve stenosis or regurgitation, or past repair or replacement
Percutaneous or surgical revascularization or active angina
Persistent atrial fibrillation
BP>160mmHg SBP or >100mmHg DBP
Comorbid inflammatory disease (e.g. RA or SLE)
Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)
Chronic use of steroids or anti-inflammatory therapy
GFR <30 mL/min
Active in a clinical trial with investigational product
Pregnant or lactating females
Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)
AdreView™ Myocardial Imaging for Risk Evaluation – A multicentre trial to guide ICD implantation in NYHA class II & III heart failure patients with 30%≤LVEF≤35%.
Currently, only about half of all patients with Heart Failure who meet the criteria for an ICD device actually receive one. Also, s…
Currently, only about half of all patients with Heart Failure who meet the criteria for an ICD device actually receive one. Also, some patients who receive an ICD device do not benefit from the device but rather incur the increased risks that are associated with the introduction of devices into the body. The purpose of this study is study is to evaluate if an AdreView™ heart function scan can help identify HF patients who may be more or less likely to benefit from having an ICD device implanted. Some research suggests that an ICD device may not be suitable for all patients with mild to moderate HF and a heart blood-pumping efficiency that is between 30% and 35% (ejection fraction 30-35%). An AdreView™ heart function scan could be used to identify people who have a high or low risk of a fatal event in the next 1 to 2 years. This additional information may make it possible to take a more accurate decision about who would and who would not benefit from an ICD device implantation. We expect that participants in the study will be involved for approximately 2¾ to 3 years and will need to come to clinic for study visits 8-9 times, depending upon if an ICD device is received as part of the patient's standard care or not. All participants involved in this study will receive an AdreView™ heart function scan. This heart function scan uses a radioactive imaging drug, AdreView™, which is already approved in the U.S. and Canada for diagnosing other diseases (e.g., cancers). AdreView™ is already approved in the United States by the U.S. Food and Drug Administration (FDA) for imaging the hearts of people with HF. We expect up to 25 people here will be in this research study out of approximately 2200 people in the entire study internationally.
• ≥18 years of age
• Females pre-menarchal, surgically sterile, postmenopausal, or negative pregnancy test
• Heart failure NYHA classes II or III for symptoms, ischemic or non-ischemic heart disease, eligible for ICD implantation
• Non-ischemic dilated cardiomyopathy or ischemic heart disease of at least 3 months duration
• 30% ≤ LVEF ≤ 35%
• Clinically stable HF (i.e., no significant changes in medication, no worsening of symptoms, no unscheduled visits to the doctor’s office) for the past 30 days
• Reasonable expectation of meaningful survival for at least 1 year
• Existing ICD or indication of ICD implantation for secondary prevention of SCD
• Hospitalized for HF or for acute coronary syndrome in the previous 40 days
• Cardiac resynchronization therapy (CRT) is planned or indicated
• Other indication for placement of device (sustained ventricular tachycardia, resuscitated sudden death, need for atrioventricular pacing)
• NYHA class I or class IV symptoms
• ACC-AHA class III or class IV (unstable) angina
• Chronic renal insufficiency (serum creatinine ≥ 3 mg/dl or 265.2 μmol/L)
• Known or suspected hypersensitivity/allergy to Iobenguane or to any of the excipients in AdreView™ (Iobenguane I123 Injection)
• Pregnant or plans to become pregnant within 2 weeks after AdreView™ administration.
• Use of medication that could interfere with the test: e.g. amitriptyline or derivatives, imipramine or derivatives, other antidepressants or drugs which inhibit the norepinephrine transporter, antihypertensives that deplete norepinephrine stores or inhibit reuptake, sympathomimetic amines or cocaine
• Medical condition that could interfere with the AdreView™ test (e.g. left ventricular assist device or prior heart transplant)
• Participation in a drug or device study within 30 days
• Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines, including pheochromocytoma
• Parkinson’s Disease or Multiple System Atrophy.
• Participation in a research study using ionizing radiation in the previous 12 months
A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart …
This research study will evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) Model 9600TFX and associated delivery systems for the aortic valve in valve procedure. If you agree to participate in this study, the investigational (experimental) Edwards SAPIEN 3 transcatheter aortic heart valve (study device) and delivery system will be used to replace your failing bioprosthetic aortic valve. The delivery systems are the Commander system (transfemoral access – through the leg) and the Certitude system (transapical and transaortic access through the heart, when a small incision is made in your chest). The study device and its delivery system are investigational, which means they are not approved for commercial use by the U.S. Food and Drug Administration (FDA) or any other governmental agency in North America for the valve in bioprosthetic valve procedure. The previous generation of SAPIEN valves, SAPIEN XT, was approved for commercial use by the FDA for a failed surgical bioprosthetic aortic valve in October 2015. The study device is a bioprosthetic heart valve made out of man-made materials and animal tissue. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the study device in its intended position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. If you agree to participate in this research study and pass the screening tests, your involvement will last approximately 10 years. You will be asked to come to clinic for study visits at 30 days, 6 months, and 12 months after the study procedure and then annually until 10 years after the procedure. We expect up to 19 people will be enrolled at Northwestern. The study expects to enroll up to 125 people internationally
Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
Bioprosthetic valve with an internal orifice diameter of 16 mm to 27 mm.
NYHA Functional Class ≥ II.
Heart Team agrees valve implantation will likely benefit the patient.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion).
Severe regurgitation (>3+) or stenosis of any other valve.
Failing valve has paravalvular regurgitation (includes those instances that have been previously treated with a plug due to paravalvular regurgitation).
Failing valve is unstable, rocking, or not structurally intact.
Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
Increased risk of embolization of THV (e.g., surgical valve that is non-stented and non-calcified).
Known bioprosthetic valve with residual mean gradient >20 mmHg at the end of the index procedure for implantation of the original valve.
EFFECTS OF DAPAGLIFLOZIN ON BIOMARKERS, SYMPTOMS AND FUNCTIONAL STATUS IN PATIENTS WITH TYPE 2 DIABETES OR PRE-DIABETES, AND PRESERVED EJECTION FRACTION HEART FAILURE (PRESERVED-HF TRIAL)
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inabil…
This study is recruiting people who have Type 2 diabetes mellitus (T2DM) or prediabetes and heart failure (Inability of the heart to pump blood with normal efficiency). The purpose of the study is to find out if a drug called dapagliflozin would be effective in improving the blood tests and symptoms related to heart failure while also treating type 2 diabetes or potentially preventing type 2 diabetes if you have pre-diabetes. To do this, dapagliflozin will be compared with placebo. The placebo will look like dapagliflozin but is inactive. Dapagliflozin lowers glucose (sugar) levels in the blood by blocking the effect of specific molecules (small particles) called sodium-glucose transporters. Under normal circumstances, the sodium-glucose transporters in the kidney prevent glucose in the blood stream from leaving the body through urine. Dapagliflozin inhibits the sodium-glucose transporters and lowers blood glucose by allowing glucose removal through the urine. Dapagliflozin may also mildly decrease body weight and lower blood pressure in certain patients. Dapagliflozin is approved by the United States Food and Drug Administration (FDA) for the treatment of type 2 diabetes. Dapagliflozin is not specifically approved for the treatment of type 2 diabetes in people with heart failure and therefore its use in this study is investigational. We expect up to 20 people here will be in this research study out of 320 people in the entire study nationally..
Documented type 2 diabetes for at least 3 months, or prediabetes. Those with type 2 diabetes must be prescribed a lifestyle intervention alone or in combination with a stable dose(s) of at least one glucose-lowering medication during the 8 weeks prior to the screening visit.
Hemoglobin A1c inclusion criteria as follows: i. Hemoglobin A1c of 6-11% (inclusive) for patients with documented type 2 diabetes receiving metformin monotherapy; ii. Hemoglobin A1c of 6.5-11% (inclusive) for patients with documented type 2 diabetes receiving any type of glucose-lowering medication (except metformin monotherapy); iii. Hemoglobin A1c of 6.0-6.9% (inclusive) for patients with documented type 2 diabetes receiving lifestyle intervention alone; iv. Hemoglobin A1c of > 5.7% and < 6.5 % for patients with pre-diabetes
Symptoms of dyspnea (NYHA class II-IV) without evidence of a non-cardiac or ischemic explanation for dyspnea
Ejection fraction (EF) ≥ 45% as determined on imaging study within 18 months of enrollment with no change in clinical status suggesting potential for deterioration in systolic function
Elevated NT-proBNP ≥ 300 pg/ml or BNP ≥ 100 pg/ml. For patients with permanent atrial fibrillation inclusion thresholds will be BNP ≥ 125 pg/mL or NTproBNP ≥ 500 pg/mL
Stable medical therapy for heart failure for 30 days
On a diuretic ≥30 days prior to screening visit and a stable diuretic therapy for 14 days
At least one of the following: i. Hospitalization for decompensated HF in the last 12 months; ii. Acute treatment for HF with intravenous loop diuretic or hemofiltration in the last 12 months; iii. Mean pulmonary capillary wedge pressure ≥15 mmHg or LV end diastolic pressure (LVEDP) ≥15 mmHg documented during catheterization at rest, or pulmonary capillary wedge pressure or LVEDP ≥25 mmHg documented during catheterization with exercise; iv. Structural heart disease evidenced by at least one of the following echo findings (any local measurement made within the 18 months prior to screening visit): 1) left atrial (LA) enlargement defined by at least one of the following: LA width ≥3.8cm or LA length ≥5.0 cm or LA area ≥20 cm2 or LA volume ≥55mL or LA volume index ≥29 mL/m2 2) OR left ventricular hypertrophy (LVH) defined by septal thickness or posterior wall thickness ≥1.1 cm.
Decompensated heart failure (hospitalization for heart failure within the 30 days prior to screening)
History of type 1 diabetes
History of diabetic ketoacidosis
Hemoglobin A1c <5.7 or >11% at the screening visit
Estimated glomerular filtration rate (eGFR) < 30 at the screening visit
Admission for an acute coronary syndrome (ST-elevation MI, non-ST-elevation MI, or unstable angina), percutaneous coronary intervention, or cardiac surgery within 60 days prior to the screening visit.
Admission for cardiac resynchronization therapy (CRT) within 90 days prior to the screening visit
Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy, or transcatheter aortic valve replacement) or CRT within the 90 days after the screening visit.
Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within 30 days of the screening visit.
History of hypersensitivity to dapagliflozin
For women of child-bearing potential: Current or planned pregnancy or currently lactating.
Life expectancy <1 year at the screening visit
Patients who are volume depleted based upon physical examination at the time of the screening or randomization visit
BNP <100 pg/mL and NTproBNP<300 pg/mL at the screening visit. For patients with permanent atrial fibrillation exclusion thresholds will be BNP<125 pg/mL and NTproBNP<500pg/mL.
Patients currently being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin) or having received treatment with any SGLT-2 inhibitor within the 12 weeks prior to the screening visit.
Average supine systolic BP <100 mmHg at the screening or randomization visit
Past or current history of bladder cancer
Donation of blood or bone marrow 12 weeks prior to the screening visit and no planned donations during the study period
Heart failure due to restrictive/infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe stenotic valve disease, and HOCM (hypertrophic obstructive cardiomyopathy).
Heart failure due to severe aortic or mitral regurgitation
Severe COPD thought to contribute to dyspnea
Isolated right heart failure due to pulmonary disease
Active and significant ischemia thought to contribute to dyspnea
Documentation of previous EF < 40% at any time
Complex congenital heart disease
Uncontrolled hypertension, defined as systolic blood pressure ≥200 mmHg during the screening visit
Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
Bariatric surgery within the past 6 months or planned bariatric surgery within the study time course.
CardioMems device implantation within previous 4 weeks or planned CardioMems implantation during study period
For echo substudy only: history of poor echo windows as judged by the investigator
For echo substudy only: patients with ventricular paced rhythm or left bundle branch block on the most recent clinically available 12-lead electrocardiogram.
For echo substudy only: permanent atrial fibrillation
Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis: EARLY TAVR trial
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for pa…
The main reason for the study is to determine whether aortic valve replacement with the Edwards SAPIEN 3 THV (the “Study Device”) is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. The Study Device is a bioprosthetic heart valve. It is an artificial device made to replace your diseased aortic heart valve. Each valve consists of a stent (mesh tube made of metal) to hold the valve in position and valve leaflets (made of biological material derived from cows) to direct the flow of blood in your heart. The Study Device and its delivery system are not approved for commercial use by the U.S. Food and Drug Administration (FDA) in patients that do not have symptoms of aortic stenosis. To date, more than 12,000 patients have been enrolled in clinical studies with an Edwards THV. The SAPIEN 3 THV that is being investigated for this study has been implanted in over 3,000 patients with symptoms of severe aortic stenosis and has been approved by FDA for those patients. Participation in the study will vary, depending upon the treatment group you are assigned. If you are in the TAVR group, your participation will be for 5 years. If you are in the Clinical Surveillance group, your participation could range from 5 to 10 years. If you are in the registry group, your participation will be for 5 years. We expect up to 166 people will participate in the main study and up to up to 150 in the registry here at Northwestern. A total of 1109 patients will participate in the main study and up to 1000 patients will participate in the registry internationally.
Severe aortic stenosis
Patient is asymptomatic
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the respective clinical site.
Patient is symptomatic.
Ilio-femoral vessel characteristics that would preclude safe placement of the introducer sheath.
Evidence of an acute myocardial infarction ≤ 1 month (30 days) before randomization.
Aortic valve is a unicuspid, bicuspid, or is non-calcified.
Severe aortic regurgitation (>3+).
Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis.
AMPLATZER™ Amulet™ Left Atrial Appendage (LAA) Occluder Randomized Controlled Trial
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the h…
This study is recruiting patients who have a condition called “nonvalvular atrial fibrillation.” Normally, electrical signals from the upper chambers of the heart (atria) travel to the lower chambers of the heart (ventricles) and cause them to beat in a regular way. During atrial fibrillation, the electrical signals in your heart are not normal and cause the upper chambers of the heart to beat too fast and irregularly. This irregular beating of the heart leads to a slowing of the blood flow in the upper chambers of the heart. In the left upper chamber, there is a small pouch called the left atrial appendage (LAA). Slowing of blood, especially in the LAA, may cause blood clots to form. Blood clots can move from the LAA and travel to the brain, causing a stroke or transient ischemic attack (TIA), also called a mini-stroke. These blood clots can also travel to other parts of the body and block blood vessels. The purpose of the AMPLATZER Amulet Left Atrial Appendage (LAA) Occluder Trial is to find out if the investigational (not yet approved by the FDA for use in the US) Amulet device is safe and effective when compared to an FDA-approved device called the WATCHMAN LAA closure device. We expect up to 25 people here will be in this research study out of 1700 people in the entire study internationally. Participants will be involved in this research study for up to 5 years. After the procedure, participants will be asked to come to clinic for 5 in-person study visits, and will be contacted via telephone by the study team 5 times.
18 years of age or older
Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3
Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6)
Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record)
Able to comply with the required medication regimen post-device implant
Able to understand and willing to provide written informed consent to participate in the trial
Able to and willing to return for required follow-up visits and examinations
Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation
Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
Indicated for chronic P2Y12 platelet therapy inhibitor
Has undergone atrial septal defect (ASD) repair or has an ASD closure device implanted
Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
Implanted with a mechanical valve prosthesis
Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the transesophageal echocardiogram (TEE/TOE) probe or required catheters, or subject has active infection or bleeding disorder)
Stroke or transient ischemic attack (TIA) within 90 days prior to randomization or implant procedure (as applicable)
Underwent any cardiac or non-cardiac intervention or surgery within 30 days prior to randomization, or intervention or surgery is planned within 60 days after implant procedure
Myocardial infarction (MI) within 90 days prior to randomization
New York Heart Association Class IV Congestive Heart Failure
Left ventricular ejection Fraction (LVEF) <30%
Symptomatic carotid artery disease (defined as >50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is <50% stenosis
Reversible cause of AF (i.e. secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
History of idiopathic or recurrent venous thromboembolism
Left atrial appendage is obliterated or surgically ligated
Resting heart rate >110 bpm
Thrombocytopenia (defined as < 70,000 platelets/mm3) or anemia with hemoglobin concentration of < 10 g/dl (i.e. anemia as determined by the investigator which would require transfusion)
Hypersensitivity to any portion of the device material or individual components of either the Amulet or Boston Scientific LAA closure device (e.g. nickel allergy)
Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this trial
Subject is pregnant or pregnancy is planned during the course of the investigation
Active endocarditis or other infection producing bacteremia
Subject has a known malignancy or other illness where life expectancy is less than 2 years
CardioMEMS HF System Post Approval Study
The objective of this Post Approval Study is to demonstrate that data collected related to the use of the CardioMEMS HF System in a commercial setting are comparable with data collected in a controlled clinical trial. The CardioMEMS HF System provides a metho…
The objective of this Post Approval Study is to demonstrate that data collected related to the use of the CardioMEMS HF System in a commercial setting are comparable with data collected in a controlled clinical trial. The CardioMEMS HF System provides a method to measure pulmonary artery (PA) pressures by using a small wireless sensor (about the size of a paperclip) implanted into the pulmonary artery (a vessel close to your heart). Once implanted, the sensor communicates through radio frequency to an antenna contained in a pillow connected to an electronic unit and then transmits this valuable information to a secure website for your doctor to review. You will be able to take these PA pressure measurements yourself at home. In addition to these home readings, your PA pressures can also be obtained in the physician’s office, clinic, or hospital. Your doctor can access the secure website to view your measurements allowing him/her to make earlier treatment changes (usually changes in medications) to manage your heart failure remotely. The CardioMEMS HF System was approved by the US Food and Drug Administration (FDA) for commercial use, and is not considered experimental. We expect up to 180 people here will be in this research study out of 1200 people in the entire study nationally. If you agree to participate, we expect that you will be in this research study for two (2) years
Diagnosis of NYHA class III heart failure
At least 1 heart failure hospitalization within previous 12 months
Patients with reduced LVEF heart failure should be receiving a beta blocker for 3 months and an ACE-I or ARB for one month unless in the investigator's opinion, the patient is intolerant to beta blockers, ACE-I or ARB
BMI ≤ 35. Patients with BMI >35 will require their chest circumference to be measured at the axillary level. If > 65 inches the patient will not be eligible for the study.
Pulmonary artery branch diameter ≥ 7mm - (implant target artery - assessed during the right heart catheterization)
History of recurrent (> 1) pulmonary embolism or deep vein thrombosis
Inability to tolerate a right heart catheterization
A major cardiovascular event (e.g., myocardial infarction, open heart surgery, stroke, etc.) within previous 2 months
Cardiac resynchronization device (CRT) implanted within previous 3 months
Glomerular Filtration Rate (GFR) < 25 ml/min (obtained within 2 weeks of implant) who are non-responsive to diuretic therapy or who are on chronic renal dialysis
Congenital heart disease or mechanical right heart valve
Likely to undergo heart transplantation or VAD within the next 6 months
Known coagulation disorders
Hypersensitivity or allergy to aspirin, and/or clopidogrel
REDUCE LAP-HF RANDOMIZED TRIAL II: A study to evaluate the Corvia Medical, Inc. IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients with Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Invest…
The purpose of this study is to evaluate the safety and effectiveness of an investigational device for heart failure symptoms. Investigational means it has not been approved by the USA Food and Drug Administration (FDA).The device is called the IASD System II, which is an “inter-atrial shunt”. The device is permanently implanted into the heart. It is designed to reduce the pressure in a part of the heart called the left atrium. This is done by creating a small opening between the left atrium and the right atrium of your heart. If it lowers the pressure in your heart at rest or during activity, it may lessen some of the symptoms you have. You have a 50% chance of receiving the device and a 50% chance of being in the control group for 2 years and then you may have the option of receiving the device This study is an FDA approved clinical trial for this device. The FDA will review the safety results and the treatment effect found in this study. If the FDA accepts the research results the FDA can approve the device for sale in the USA. In April 2016, the Study Device received CE Marking, which is an approval that allows it to be sold in the European Union. If you agree to participate in this study, we expect that you will be involved for about five (5) years. Being in this study requires regular doctor visits. There are visits for testing before the procedure. After the procedure, there are visits at 1 month, 3 months, 6 months and 12 months, and then yearly visits until 5 years after the procedure. The study is over when all the subjects have had their last doctor visit. We expect up to 12 people here will be in this research study out of 700 people in the entire study internationally
INCLUSION CRITERIA: 1. Chronic symptomatic heart failure (HF) documented by the following:
a. Symptoms of HF requiring current treatment with diuretics for ≥ 30 days
b. New York Heart Association (NYHA) class II with a prior history of > NYHA class II; NYHA class III, or ambulatory NYHA class IV symptoms (paroxysmal nocturnal dyspnea, orthopnea, dyspnea on mild or moderate exertion) at screening visit; or signs (any rales post cough, chest x-ray demonstrating pulmonary congestion,) within past 12 months; AND
c. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV), or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility), within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.
2. Ongoing stable GDMT HF management and management of potential comorbidities according to the 2013 ACCF/AHA Guidelines for the management of Heart Failure, with no significant changes (>100% increase or 50% decrease), excluding diuretic dose changes, for a minimum of 4 weeks prior to screening which is expected to be maintained for 6 months.
3. Age ≥ 40 years old
4. Site determined echocardiographic LV ejection fraction ≥40% within the past 6 months,
without documented ejection fraction <30% in the 5 years prior to study entry.
5. Site determined elevated PCWP with a gradient compared to right atrial pressure (RAP)
a. End-expiratory PCWP during supine ergometer exercise ≥ 25mm Hg, and greater than
RAP by ≥ 5 mm Hg. OR
b. End-expiratory resting PCWP >15mm Hg, and greater than RAP by ≥ 5 mm Hg.
6. Site determined echocardiographic evidence of diastolic dysfunction documented by one or more of the following:
a. LA diameter > 4 cm; or
b. Diastolic LA volume > 50, LA volume index > 28 ml/m2 or c. Lateral e’ < 10 cm/s; or
d. Septal e’ < 8 cm/s; or
e. Lateral E/e’ > 10 ; or f. Septal E/e’ > 15
7. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB or EC
8. Subject is willing to comply with clinical investigation procedures and agrees to return for all
required follow-up visits, tests, and exams
9. Trans-septal catheterization and femoral vein access to the right atrium is determined to be feasible by site interventional cardiology investigator. EXCLUSION CRITERIA 1. MI and/or percutaneous cardiac intervention within past 3 months; CABG in past 3 months, or current indication for coronary revascularization; AVR (surgical AVR or TAVR) within the past 12 months.
2. Cardiac resynchronization therapy initiated within the past 6 months
3. Advanced heart failure defined as one or more of the below:
a. ACC/AHA/ESC Stage D heart failure, Non-ambulatory NYHA Class IV HF;
b. Cardiac index < 2.0 L/min/m2
c. Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months d. Patient is on the cardiac transplant waiting list
4. Inability to perform 6 minute walk test (distance < 50 m), OR 6 minute walk test > 600m
5. The patient has verified that the ability to walk 6 minutes is limited primarily by joint, foot, leg, hip or back pain; unsteadiness or dizziness or lifestyle and not by shortness of breath and/or fatigue and/or chest pain.
6. Unwilling or unable (per PhysIQ protocol) to wear tele-monitoring patch.
7. Known clinically significant un-revascularized coronary artery disease, defined as: epi-cardial coronary artery stenosis associated with angina or other evidence of coronary ischemia.
8. History of stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT), or pulmonary emboli within the past 6 months
9. Known clinically significant untreated carotid artery stenosis likely to require intervention.
10. Presence of hemodynamically significant valve disease assessed by the site cardiologist and defined as:
a. Mitral valve disease defined as grade ≥ 3+ MR or > mild MS
b. Tricuspid valve regurgitation defined as grade ≥ 2+ TR;
c. Aortic valve disease defined as ≥ 2+ AR or > moderate AS
11. Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis or other infiltrative cardiomyopathy (e.g. hemochromatosis, sarcoidosis)
12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue);
or has a documented coagulopathy
13. Atrial fibrillation with resting HR > 100 BPM
14. Resting arterial oxygen saturation < 95% on room air
15. Significant hepatic impairment defined as 3X upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase
16. Right ventricular dysfunction, assessed by the site cardiologist and defined as a. More than mild RV dysfunction as estimated by TTE; OR
b. TAPSE < 1.4 cm; OR
c. RV size ≥ LV size as estimated by TTE; OR
d. Ultrasound or clinical evidence of congestive hepatopathy; OR
e. Evidence of RV dysfunction defined by TTE as an RV fractional area change < 35%;
17. Resting RAP > 14 mmHg
18. Evidence of significant pulmonary hypertension defined as PVR > 4 Wood units
19. Chronic pulmonary disease requiring continuous home oxygen, OR significant chronic pulmonary disease defined as FEV1 <1L.
20. Hemoglobin <10 g/dl
21. Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Note: trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational
22. Life expectancy less than 12 months for known non-cardiovascular reasons
23. Echocardiographic evidence of intra-cardiac mass, thrombus or vegetation
24. Known or suspected allergy to nickel
25. Fertile women
26. Currently requiring dialysis; or estimated-GFR <25ml/min/1.73 m2 by CKD-Epi equation
27. Systolic blood pressure >170 mm Hg.
28. Subjects with existing atrial septal defects. Subjects with a patent foramen ovale (PFO), who meet PCWP criteria despite the PFO, are not excluded.
29. Subjects on significant immunosuppressive treatment or on systemic steroid treatment (>10 mg prednisone/day).
30. Severe obstructive sleep apnea not treated with CPAP or other measures
31. Severe depression and/or anxiety
32. In the opinion of the investigator, the subject is not an appropriate candidate for the study
Assessment of the WATCHMAN(TM) Device in Patients Unsuitable for Oral Anticoagulation
This study will evaluate the safety and effectiveness of the WATCHMANTM Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by…
This study will evaluate the safety and effectiveness of the WATCHMANTM Device in patients who cannot use oral anticoagulation (OAC) therapy (blood thinner medication). Participants in this study will be assigned by chance (“randomized”) to one of two groups: the Device Group or the Control Group. There will be two people assigned to the Device Group for every one person assigned to the Control Group. Participants in the Device Group will be scheduled for WATCHMANTM Device implantation. Participants the Control Group will not have the device implanted and will be prescribed single antiplatelet therapy or no therapy for the duration of the trial at the discretion of the study physician. In this study, the WATCHMANTM Device itself and the implantation procedure are the same as the FDA approved WATCHMANTM. The only difference is that no OAC therapy will be administered after implant. Therefore, the use of the WATCHMANTM Device in this study is considered “investigational” because the WATCHMANTM Device has not been approved by the FDA for use without short-term OAC therapy. If you agree to participate in this study, we expect that you will be in this research study for about 5 years. During this time, you will be asked to come to clinic for 6-7 study visits, and the study team will contact you by telephone for 5 phone “visits”. We expect up to 70 people here will be in this research study out of 888 people in the entire study internationally.
The subject is of legal age to participate in the study per the laws of their respective geography.
The subject has documented paroxysmal, persistent, permanent or long-term/longstanding persistent non-valvular atrial fibrillation (i.e., the subject has not been diagnosed with rheumatic mitral valvular heart disease).
The subject has a calculated CHA2DS2-VASc score of 2 or greater.
The subject is deemed by two study physicians to be unsuitable for oral anticoagulation.
The subject is deemed by a study physician to be suitable for the defined protocol pharmacologic regimen of aspirin and clopidogrel therapy following WATCHMAN Closure Device implant.
The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
The subject is able and willing to return for required follow-up visits and examinations.
The subject is unable or unwilling to return for required follow-up visits and examinations.
The subject had or is planning to have any invasive cardiac procedure within 30 days prior to randomization (e.g., cardioversion, ablation).
The subject is planning to have any cardiac or non-cardiac invasive or surgical procedure that would necessitate stopping or modifying the protocol required medication regimen within 90 days after the WATCHMAN Closure Device implant (e.g., cardioversion, ablation, cataract surgery).
The subject had a prior stroke (of any cause) or TIA within the 30 days prior to randomization.
The subject had a prior BARC type 3 or 4 bleeding event within the 14 days prior to randomization. Lack of resolution of related clinical sequelae, or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event.
The subject has a history of atrial septal repair or has an ASD/PFO device.
The subject has an implanted mechanical valve prosthesis in any position.
The subject suffers from New York Heart Association Class IV Congestive Heart Failure.
The subject has LVEF < 30%.
The subject is of childbearing potential and is, or plans to become pregnant during the time of the study (method of assessment upon study physician's discretion).
The subject is currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
The subject has a life expectancy of less than two years.
The subject has a known or suspected hypercoagulable state.