Mitral Regurgitation Clinical Trial
— CLASP IID/IIFOfficial title:
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Status | Recruiting |
Enrollment | 1247 |
Est. completion date | April 30, 2030 |
Est. primary completion date | January 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Eighteen (18) years of age or older - Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements. - Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only). - Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only) - Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip - Mitral regurgitation (3+ to 4+) by echo - Suitable valve and regurgitant jet morphology - Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only) - LVEF = 20% (and = 50%; CLASP IIF cohort only) Exclusion Criteria: - Patient in whom a TEE is contraindicated or screening TEE is unsuccessful - Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation - Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status =5 heart transplantation) (ACC/AHA Stage D heart failure) - Clinically significant, untreated coronary artery disease - Recent stroke - Other severe valve disorders requiring intervention - Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months - Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair) - Severe tricuspid regurgitation or tricuspid valve disease requiring surgery - Active rheumatic heart disease or rheumatic etiology for MR - Severe aortic stenosis or regurgitation - Known history of untreated, severe carotid stenosis - Recent deep vein thrombosis (DVT) or pulmonary embolism (PE) - Severe COPD - Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception - Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator - Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment - Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship |
Country | Name | City | State |
---|---|---|---|
Canada | Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval | Québec | |
Canada | St. Michael's Hospital | Toronto | Ontario |
Canada | St. Pauls Hospital | Vancouver | British Columbia |
Germany | Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum | Bad Oeynhausen | |
Germany | Herzzentrum Universitätsklinikum Koln | Cologne | |
Germany | Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden | Dresden | |
Germany | Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum | Essen | |
Germany | Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie | Gießen | |
Germany | Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie | Hamburg | |
Germany | Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie | Heidelberg | |
Germany | Herzzentrum Leipzig Universitätsklinik für Kardiologie | Leipzig | |
Germany | Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz | Mainz | |
Germany | Medizinische Klinik I LMU München Campus Grosshadern | München | |
Germany | Helios Klinikum Siegburg | Siegburg | |
Germany | ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II | Ulm | |
Switzerland | University Hospital Bern | Bern | |
United States | Albany Medical College | Albany | New York |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Emory University Hospital and Emory University Hospital Midtown | Atlanta | Georgia |
United States | Piedmont Healthcare | Atlanta | Georgia |
United States | University of Colorado Hospital | Aurora | Colorado |
United States | The University of Alabama at Birmingham | Birmingham | Alabama |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Brigham and Woman's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | State University of New York at Buffalo | Buffalo | New York |
United States | St. Vincent Heart Center | Carmel | Indiana |
United States | Atrium Health/Sanger Heart & Vascular Institute | Charlotte | North Carolina |
United States | University of Virginia | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | OhioHealth Research Institute | Columbus | Ohio |
United States | The Ohio State University Medical Center | Columbus | Ohio |
United States | Medical City Dallas | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida |
United States | Baylor College of Medicine | Houston | Texas |
United States | HCA Houston Healthcare Medical Center | Houston | Texas |
United States | Houston Methodist Hospital | Houston | Texas |
United States | The University of Texas Health Science Center at Houston | Houston | Texas |
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | St.Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Scripps Memorial Hospital La Jolla | La Jolla | California |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | PIH Health Good Samaritan Hospital | Los Angeles | California |
United States | Medical Center of the Rockies | Loveland | Colorado |
United States | Fairview Health Services | Maplewood | Minnesota |
United States | Mount Sinai | Miami Beach | Florida |
United States | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin |
United States | NYU Langone Hospital - Long Island | Mineola | New York |
United States | Morristown Medical Center | Morristown | New Jersey |
United States | Advocate Health & Hospitals Corp/Edward Heart Hospital | Naperville | Illinois |
United States | NCH Healthcare System Naples | Naples | Florida |
United States | Centennial Medical Center | Nashville | Tennessee |
United States | Saint Thomas Heart at Saint Thomas West | Nashville | Tennessee |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Rutgers-RWJMS | New Brunswick | New Jersey |
United States | Ochsner Medical Center | New Orleans | Louisiana |
United States | Columbia University Medical Center/New York Presbyterian Hospital | New York | New York |
United States | Lenox Hill Hospital and North Shore University | New York | New York |
United States | NYU Langone Health | New York | New York |
United States | Sentara Norfolk General Hospital | Norfolk | Virginia |
United States | Integris Health Baptist Medical Center | Oklahoma City | Oklahoma |
United States | Oklahoma Cardiovascular | Oklahoma City | Oklahoma |
United States | St. Joseph Hospital | Orange | California |
United States | UC Irvine | Orange | California |
United States | AdventHealth Orlando | Orlando | Florida |
United States | Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
United States | Abrazo Arizona Heart Hospital | Phoenix | Arizona |
United States | Arizona Cardiovascular Research Center | Phoenix | Arizona |
United States | Banner University Medical Center | Phoenix | Arizona |
United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
United States | The Heart Hospital Baylor Plano | Plano | Texas |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Providence St. Vincent Medical Center | Portland | Oregon |
United States | Chippenham Johnston & Willis Medical Center | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Rochester General Hospital | Rochester | New York |
United States | St. Francis Hospital | Roslyn | New York |
United States | Sutter Medical Center-Sacramento | Sacramento | California |
United States | UC Davis Medical Center | Sacramento | California |
United States | Washington University/Barnes Jewish Hospital | Saint Louis | Missouri |
United States | Intermountain Medical Center | Salt Lake City | Utah |
United States | Kaiser Permanente San Francisco | San Francisco | California |
United States | Sutter Bay Area | San Francisco | California |
United States | University of California, San Francisco | San Francisco | California |
United States | Swedish Medical Center | Seattle | Washington |
United States | University of Washington | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | Los Robles Hospital and Medical Center | Thousand Oaks | California |
United States | TMC Healthcare | Tucson | Arizona |
United States | Oklahoma Heart Institute | Tulsa | Oklahoma |
United States | Medstar Washington Hospital Center | Washington | District of Columbia |
United States | Cleveland Clinic Florida | Weston | Florida |
United States | Cardiovascular Research Institute of Kansas | Wichita | Kansas |
United States | Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg | Wormleysburg | Pennsylvania |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
United States, Canada, Germany, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). | 30 days. | ||
Primary | PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. | 6 months | ||
Primary | PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. | From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up | ||
Secondary | Rates of various adverse events | Rates of various adverse events at 6 and 12 months | 6 months; 12 months | |
Secondary | Functional Improvement (increase in 6 minute walk test in meters) | Increase in 6 minute walk test in meters | 30 days , 6 months, 1 year | |
Secondary | Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years | Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life | 30 days , 6 months, 1 year, 2 year | |
Secondary | Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years | Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life | 30 days, 6 months, 1 year, 2 year | |
Secondary | Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through | Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life | 30 days, 6 months, 1 year, 2 year |
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