Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

Mitral Regurgitation Clinical Trial

— CLASP IID/IIF  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706833
• Other study ID #: 2018-07
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: April 30, 2030

Study information

• Verified date: March 2024
• Source: Edwards Lifesciences
• Contact: Edwards TMTT Clinical Affairs
• Phone: (949) 250-2500
• Email: TMTT_Clinical[@]edwards.com
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Degenerative Mitral Valve Disease
• Functional Mitral Regurgitation
• Mitral Insufficiency
• Mitral Regurgitation
• Mitral Valve Insufficiency

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	UC San Francisco	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