A Clinical Evaluation of the Safety and Effectiveness of the MitraClip® System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects (COAPT Recruitment Closed). COAPT CAS (Recruitment Closed)

Status: Active, not recruiting
Location: See all (86) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

⁃ 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:

• 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).

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Arizona
Banner Good Samaritan Medical Center
Phoenix
Scottsdale Healthcare Hospitals
Scottsdale
California
Scripps Green Hospital
La Jolla
Cedars-Sinai Medical Center
Los Angeles
El Camino Hospital
Mountain View
University California Davis Medical Center
Sacramento
Kaiser Permanente - San Francisco Hospital
San Francisco
Stanford Hospital and Clinics
Stanford
Colorado
University of Colorado Hospital
Denver
Connecticut
Hartford Hospital
Hartford
Yale - New Haven Hospital
New Haven
Washington, D.c.
Medstar Washington Hospital Center
Washington
Florida
Morton Plant Hospital
Clearwater
Mount Sinai Medical Center
Miami
Florida Hospital Orlando
Orlando
Sarasota Memorial Hospital
Sarasota
Tallahassee Memorial Hospital
Tallahassee
Tampa General Hospital
Tampa
Georgia
Emory University Hospital
Atlanta
Piedmont Hospital Atlanta
Atlanta
Hawaii
The Queen's Medical Center
Honolulu
Iowa
Iowa Heart Center
Des Moines
Illinois
Northwestern Memorial Hospital
Chicago
Rush University Medical Center
Chicago
Evanston Hospital
Evanston
Indiana
St. Vincent Heart Center of Indiana
Indianapolis
Kansas
University of Kansas Hosp Authority
Kansas City
Via Christi
Wichita
Kentucky
St. Joseph's Hospital - Lexington, KY
Lexington
Jewish Hospital
Louisville
Louisiana
Ochsner Clinic Foundation
New Orleans
Massachusetts
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Tufts Medical Center
Boston
Maryland
University of Maryland Baltimore
Baltimore
Maine
Maine Medical Center
Portland
Michigan
University of Michigan Hospitals
Ann Arbor
Henry Ford Hospital
Detroit
William Beaumont Hospital
Royal Oak
Minnesota
Abbott Northwestern Hospital
Minneapolis
University of Minnesota
Minneapolis
Mayo Foundation for Med Edu And Research
Rochester
Missouri
Saint Luke's Hospital
Kansas City
Barnes Jewish Hospital
Saint Louis
Montana
St. Patrick Hospital
Missoula
North Carolina
Carolinas Medical Center
Charlotte
Duke University Medical Center
Durham
Vidant Medical Center
Greenville
Nebraska
Nebraska Heart Institute Heart Hospital
Lincoln
New Jersey
Cooper University Hospital
Camden
Morristown Medical Center
Morristown
New York
North Shore
Manhasset
Columbia University Medical Center / New York Presbyterian Hospital
New York
Mount Sinai Medical Center
New York
NYP Weill Cornell Medical Center
New York
NYU Langone Medical Center
New York
St. Francis Hospital
Roslyn
Ohio
The Christ Hospital
Cincinnati
Cleveland Clinic
Cleveland
Ohio State University Medical Center
Columbus
Riverside Methodist Hospital
Columbus
Oklahoma
Oklahoma Heart Hospital
Oklahoma City
Oregon
Oregon Health and Science University
Portland
Providence St. Vincent Medical Center
Portland
Pennsylvania
Hospital of University Pennsylvania
Philadelphia
Temple University Hospital
Philadelphia
UPMC Presbyterian
Pittsburgh
Pinnacle Health at Harrisburg Hospital
Wormleysburg
South Carolina
Medical University of South Carolina
Charleston
Tennessee
St. Thomas Hospital
Nashville
Texas
Seton Medical Center Austin
Austin
Baylor Heart and Vascular Hospital
Dallas
UT Southwestern Medical Center
Dallas
Houston Methodist Hospital
Houston
Memorial Hermann Hospital
Houston
Utah
Intermountain Medical Center
Murray
Virginia
University of Virginia
Charlottesville
Virginia Commonwealth University Medical Center
Richmond
Carilion Roanoke Memorial Hospital
Roanoke
Washington
Swedish Medical Center Cherry Hill Campus
Seattle
Other Locations
Canada
University of Alberta
Edmonton
Hamilton Health Sciences
Hamilton
Montreal Heart Institute
Montreal
St Michael's Hospital
Toronto
St Paul's - Providence Health Care
Vancouver
Time Frame
Start Date: August 2012
Estimated Completion Date: July 2024
Participants
Target number of participants: 776
Treatments
Experimental: MitraClip System
Percutaneous mitral valve repair using MitraClip System
No Intervention: Control Group
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.
Experimental: COAPT CAS Group
Percutaneous mitral valve repair using MitraClip System
Authors
Mark Vesley, Garrett Stewart, Sarah Gualano, Osvaldo S Gigliotti, Oluseun Alli, John Peterson, Brian Whisenant, Igor Palacios, James Gammie, Cezar Staniloae, James Hermiller, George Hanzel, Mubashir Mumtaz, Brijeshwar Maini, Raymond McKay, Alan Yeung, Steven Yakubov, Steven Bolling, Samir Kapadia, Omar Nass, Andreas Brieke, Nirat Beohar, Lowell Satler, Ethan Korngold, Joseph Wight, Jacob Mishell, Samin Sharma, John Forrest, Christian Spies, Susheel Kodali, Wayne Batchelor, Richard Smalling, Robert Kipperman, Gregg Stone, Andrew D Berke, Neal Kleiman, Paul Grayburn, William Gray, Anson Jay C Smith, David G Rizik, Michael Mack, Guy Reeder, Charanjit Rihal, Mario Goessl, John Lasala, Michael Flaherty, Navin Kapur, Vasilis Babaliaros, Saurabh Gupta, Firas Zahr, Mark Wiley, Ramesh Daggubati, Saibal Kar, Daniel Steinberg, Robert Salley, Kenneth Huber, Evelio Rodriguez, Zachary Gertz, Michael J Rinaldi, Ted Feldman, Juan Crestanello, Jason Foerst, Gladwin Das, Mohammad Ghani, John Williams, Howard C Herrmann, Andrew Wang, Janah Aji, Ian Sarembock, James Slater, Joshua Rovin, Magdi Ghali, Vivek Rajagopal, Mark Sanz, Jason Rogers, Patrick McCarthy, Matthew Price, Howard Cohen, Ricardo Yaryura, Adam Greenbaum, Clifford Kavinsky, Wesley Pedersen, Robert Boone, JoAnn Lindenfeld, Andy Taussig, Tim Byrne, Neal Fam, Craig D Miller, Chiu S Wong, Thompson J Sullebarger, Tod J Maddux, David Adams, Chad Rammohan, Anita Asgar, Jamie Kennedy, William T Abraham, Shamir Mehta, Scott D Lim, Steven Jenkins
Sponsors
Leads: Abbott Medical Devices

This content was sourced from clinicaltrials.gov