Heart Failure Clinical Trial

Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial) and COAPT CAS

Summary

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart failure patients with moderate-to-severe or severe functional mitral regurgitation.

Approximately 610 subjects will be randomized at up to 100 investigational sites with approximately 305 subjects targeted to receive the study device. COAPT study completed recruiting subjects in June 2017.

As part of the COAPT trial, a subset of patients will be registered in the cardiopulmonary exercise (CPX) sub-study. The objective of this sub-study is to evaluate the exercise responses in a sub-cohort of COAPT subjects who receive MitraClip device (Device group) compared to the Control group who do not receive MitraClip device. (Note: the CPX Sub-study subjects will contribute to the analyses of the COAPT primary and secondary endpoints)

As an extension of the COAPT RCT trial, COAPT CAS study will be conducted after COAPT enrollment is complete under the same investigational device exemption (IDE(G120024)). The objective of this study is to evaluate the MitraClip® NT System for the treatment of clinically significant functional mitral regurgitation (FMR) in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. The anticipated Study Completion Date is July 2024. COAPT CAS completed recruiting subjects in March 2019.

View Full Description

Full Description

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group).

As part of the COAPT trial, a subset of patients (at least 50 up to 100 in total) will be registered in the CPX Sub-study, which is designed as a prospective, randomized (1:1 ratio to the MitraClip or no MitraClip device), parallel-controlled, multicenter study registering approximately 50-100 subjects in up to 50 qualified US sites from the COAPT trial. Subjects registered and randomized in the CPX Sub-study will contribute to the total enrollment approximately of 610 subjects in the COAPT trial. Roll-in subjects will not participate in the CPX Sub-study.

The COAPT CAS study is designed as a prospective, multicenter, single arm, continued access registry study. A maximum of 800 subjects (anticipated) will be registered from up to 75 sites in the United States. The enrollment will end once pre-market approval (PMA) of the proposed expanded indication of MitraClip System is obtained. Active follow-up of patients will be performed through 12 months with scheduled visits at 30 days and 12 months. The national Trans catheter Valve Therapy Registry (TVT Registry) will be used for data collection through 12 months. Annual follow-up data from 2 years through year 5 post-implant will be obtained by linkage to the Centers for Medicare and Medicaid Services (CMS) Claims database.

COAPT CAS data may be used to support the PMA application of the labeling claims for the treatment of moderate to severe or severe FMR in symptomatic heart failure subjects. This single arm registry will provide valuable new information regarding use of the MitraClip® NT System under more "real world" conditions.

COAPT study completed recruiting subjects in June 2017. COAPT CAS completed recruiting subjects in March 2019. A total of 162 subjects were enrolled in the COAPT CAS Group.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.

Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.

Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy including Guideline Directed Medical Therapy (GDMT) and at least 30 days after:

a greater than 100% increase or greater than 50% decrease in dose of GDMT
revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%)
In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or GDMT). The Eligibility Committee must also concur that the subject has been adequately treated.
New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group.

The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).

Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on GDMT and at least 30 days after:

a greater than 100% increase or greater than 50% decrease in dose of GDMT
revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%).

Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI).

Note: The method must provide a quantitative readout (not a visual assessment).

The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.
Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN).
Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
Age 18 years or older.
The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial.
The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.
Left Ventricular End Systolic Dimension (LVESD) is ≤ 70 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject registration.

For the CPX Sub-study: Subjects have to meet the COAPT study eligibility criteria to be registered in the CPX Sub-study.

COAPT CAS study Inclusion Criteria:

1. Subjects must meet all of the above COAPT RCT inclusion criteria, and must have national Medicare coverage by the Centers for Medicare and Medicaid Services (CMS).

Exclusion Criteria:

Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
Untreated clinically significant coronary artery disease requiring revascularization.
Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
Percutaneous coronary intervention within 30 days prior to subject registration.
Transcatheter aortic valve replacement (TAVR) within 30 days prior to subject registration.
Tricuspid valve disease requiring surgery or transcatheter intervention.
Aortic valve disease requiring surgery.
Cerebrovascular accident within 30 days prior to subject registration.
Severe symptomatic carotid stenosis (> 70% by ultrasound).
Carotid surgery or stenting within 30 days prior to subject registration.
American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.

Presence of any of the following:

Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
Hemodynamic instability requiring inotropic support or mechanical heart assistance.
Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction as assessed by site.
Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.

Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:

Insufficient mobile leaflet available for grasping with the MitraClip device
Evidence of calcification in the grasping area
Presence of a significant cleft in the grasping area
Lack of both primary and secondary chordal support in the grasping area
Leaflet mobility length < 1 cm
Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
Life expectancy < 12 months due to non-cardiac conditions.
Modified Rankin Scale ≥ 4 disability.
Status 1 heart transplant or prior orthotopic heart transplantation.
Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
Active infections requiring current antibiotic therapy.
Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.

Pregnant or planning pregnancy within next 12 months.

Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release.

Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.

For the CPX Sub-study: Subjects who have any contraindications to CPX and are not capable of performing CPX per investigator's assessment should not be registered in the CPX Sub-study.

COAPT CAS study Exclusion Criteria:

1. Subjects must not meet any of the above COAPT RCT exclusion criteria.

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Study is for people with:

Heart Failure

Estimated Enrollment:

776

Study ID:

NCT01626079

Recruitment Status:

Active, not recruiting

Sponsor:

Abbott Medical Devices

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There are 84 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
Banner Good Samaritan Medical Center
Phoenix Arizona, 85006, United States
Scottsdale Healthcare Hospitals
Scottsdale Arizona, 85258, United States
Scripps Green Hospital
La Jolla California, 92037, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
El Camino Hospital
Mountain View California, 94040, United States
University California Davis Medical Center
Sacramento California, 95817, United States
Kaiser Permanente - San Francisco Hospital
San Francisco California, 94115, United States
Stanford Hospital and Clinics
Stanford California, 94305, United States
University of Colorado Hospital
Denver Colorado, 80045, United States
Hartford Hospital
Hartford Connecticut, 06106, United States
Yale - New Haven Hospital
New Haven Connecticut, 06510, United States
Medstar Washington Hospital Center
Washington District of Columbia, 20010, United States
Morton Plant Hospital
Clearwater Florida, 33756, United States
Mount Sinai Medical Center
Miami Florida, 33140, United States
Florida Hospital Orlando
Orlando Florida, 32803, United States
Sarasota Memorial Hospital
Sarasota Florida, 34239, United States
Tallahassee Memorial Hospital
Tallahassee Florida, 32308, United States
Tampa General Hospital
Tampa Florida, 33606, United States
Piedmont Hospital Atlanta
Atlanta Georgia, 30309, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
The Queen's Medical Center
Honolulu Hawaii, 96813, United States
Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Evanston Hospital
Evanston Illinois, 60201, United States
St. Vincent Heart Center of Indiana
Indianapolis Indiana, 46290, United States
Iowa Heart Center
Des Moines Iowa, 50266, United States
University of Kansas Hosp Authority
Kansas City Kansas, 66160, United States
Via Christi
Wichita Kansas, 66866, United States
St. Joseph's Hospital - Lexington, KY
Lexington Kentucky, 40504, United States
Jewish Hospital
Louisville Kentucky, 40245, United States
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Maine Medical Center
Portland Maine, 04102, United States
University of Maryland Baltimore
Baltimore Maryland, 21201, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston Massachusetts, 02115, United States
University of Michigan Hospitals
Ann Arbor Michigan, 48109, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
William Beaumont Hospital
Royal Oak Michigan, 48073, United States
Abbott Northwestern Hospital
Minneapolis Minnesota, 55407, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Foundation for Med Edu And Research
Rochester Minnesota, 55905, United States
Saint Luke's Hospital
Kansas City Missouri, 64111, United States
Barnes Jewish Hospital
Saint Louis Missouri, 63110, United States
St. Patrick Hospital
Missoula Montana, 59802, United States
Nebraska Heart Institute Heart Hospital
Lincoln Nebraska, 68526, United States
Cooper University Hospital
Camden New Jersey, 08103, United States
Morristown Medical Center
Morristown New Jersey, 07960, United States
North Shore
Manhasset New York, 11030, United States
NYU Langone Medical Center
New York New York, 10016, United States
Mount Sinai Medical Center
New York New York, 10029, United States
Columbia University Medical Center / New York Presbyterian Hospital
New York New York, 10032, United States
NYP Weill Cornell Medical Center
New York New York, 10065, United States
St. Francis Hospital
Roslyn New York, 11576, United States
Carolinas Medical Center
Charlotte North Carolina, 28203, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Vidant Medical Center
Greenville North Carolina, 27834, United States
The Christ Hospital
Cincinnati Ohio, 45219, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
Ohio State University Medical Center
Columbus Ohio, 43210, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Oklahoma Heart Hospital
Oklahoma City Oklahoma, 73120, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Hospital of University Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Temple University Hospital
Philadelphia Pennsylvania, 19140, United States
UPMC Presbyterian
Pittsburgh Pennsylvania, 15213, United States
Pinnacle Health at Harrisburg Hospital
Wormleysburg Pennsylvania, 17043, United States
Medical University of South Carolina
Charleston South Carolina, 29403, United States
St. Thomas Hospital
Nashville Tennessee, 37205, United States
Seton Medical Center Austin
Austin Texas, 78705, United States
Baylor Heart and Vascular Hospital
Dallas Texas, 75204, United States
UT Southwestern Medical Center
Dallas Texas, 75235, United States
Houston Methodist Hospital
Houston Texas, 77030, United States
Memorial Hermann Hospital
Houston Texas, 77030, United States
Intermountain Medical Center
Murray Utah, 84107, United States
University of Virginia
Charlottesville Virginia, 22908, United States
Virginia Commonwealth University Medical Center
Richmond Virginia, 23284, United States
Carilion Roanoke Memorial Hospital
Roanoke Virginia, 24014, United States
Swedish Medical Center Cherry Hill Campus
Seattle Washington, 98122, United States
St Paul's - Providence Health Care
Vancouver British Columbia, V6Z 1, Canada
Hamilton Health Sciences
Hamilton Ontario, L8L 2, Canada
St Michael's Hospital
Toronto Ontario, M5B 1, Canada
Montreal Heart Institute
Montreal Quebec, H1T 1, Canada
University of Alberta
Edmonton , , Canada

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

776

Study ID:

NCT01626079

Recruitment Status:

Active, not recruiting

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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