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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03706833
Other study ID # 2018-07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 30, 2018
Est. completion date April 30, 2030

Study information

Verified date June 2024
Source Edwards Lifesciences
Contact Edwards TMTT Clinical Affairs
Phone (949) 250-2500
Email TMTT_Clinical@edwards.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Description:

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 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) Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Switzerland, 

Outcome

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
See also
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Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
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Not yet recruiting NCT01431222 - Abrogation of Mitral Regurgitation Using the MitraClip System in High-Risk Patients Unsuitable for Surgery Phase 4
Not yet recruiting NCT03870516 - Left Chamber Function in Mitral Regurgitation and Predicting Outcome After Replacement and Targeting for Early Surgery N/A
Active, not recruiting NCT03230747 - SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral Regurgitation N/A
Enrolling by invitation NCT04031274 - Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter (AMTRAC) Valve Registry
Completed NCT05836480 - Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
Completed NCT05836532 - Long Term Results of Surgical and Percutaneous Double Orefices Mitral Repair in Patient With p2 Prolapse Causing Degenerative Mitral Regurgitation
Completed NCT05850026 - Mitral Regurgitation in Hypertrophic Obstructive Cardiomyopathy: Fix it in a Simple, Effective and Durable Way!
Recruiting NCT03975998 - Dutch-AMR: Early Mitral Valve Repair Versus Watchful Waiting in Asymptomatic Patients With Severe Mitral Regurgitation
Completed NCT01162083 - Identifying an Ideal Cardiopulmonary Exercise Test Parameter N/A
Suspended NCT00787293 - Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients Phase 2