Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial

NCT03706833 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2018-07
• Study Type: interventional
• Target: 1,247
• Locations: 4 countries
• Sites: 86

Brief 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)

Conditions

Degenerative Mitral Valve Disease; Mitral Regurgitation; Mitral Insufficiency; Functional Mitral Regurgitation

Outcome Measures

Primary Outcomes (3)

• 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.

• 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

• 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 Outcomes (5)

• Rates of various adverse events

  6 months; 12 months

• Functional Improvement (increase in 6 minute walk test in meters)

  30 days , 6 months, 1 year

• Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years

  30 days , 6 months, 1 year, 2 year

• 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

  30 days, 6 months, 1 year, 2 year

• Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through

  30 days, 6 months, 1 year, 2 year

Study Arms (5)

Edwards PASCAL System - CLASP IID

EXPERIMENTAL

Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation

Device: Edwards PASCAL System

Abbott Mitraclip System - CLASP IID

ACTIVE COMPARATOR

Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation

Device: Abbott Mitraclip System

Edwards PASCAL System - CLASP IIF

EXPERIMENTAL

Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation

Device: Edwards PASCAL System

Abbott Mitraclip System - CLASP IIF

ACTIVE COMPARATOR

Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation

Device: Abbott Mitraclip System

Edwards PASCAL System - Single-Arm Registry

EXPERIMENTAL

Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.

Device: Edwards PASCAL System

Interventions

Edwards PASCAL System DEVICE

Transcatheter mitral valve repair with the Edwards PASCAL System

Also known as: Transcatheter Mitral Valve repair (TMVr)

Edwards PASCAL System - CLASP IID; Edwards PASCAL System - CLASP IIF; Edwards PASCAL System - Single-Arm Registry

Abbott Mitraclip System DEVICE

Transcatheter mitral valve repair with the Abbott Mitraclip System

Also known as: Transcatheter Mitral Valve repair (TMVr)

Abbott Mitraclip System - CLASP IID; Abbott Mitraclip System - CLASP IIF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (86)

Banner University Medical Center

Phoenix, Arizona, 85006, United States

Location

Abrazo Arizona Heart Hospital

Phoenix, Arizona, 85016, United States

Location

TMC Healthcare

Tucson, Arizona, 85712, United States

Location

Scripps Memorial Hospital La Jolla

La Jolla, California, 92071, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UC Irvine

Orange, California, 92868, United States

Location

Sutter Medical Center-Sacramento

Sacramento, California, 95618, United States

Location

Sutter Bay Area

San Francisco, California, 94109, United States

Location

Kaiser Permanente San Francisco

San Francisco, California, 94118, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Los Robles Hospital and Medical Center

Thousand Oaks, California, 91360, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, 32605, United States

Location

Mount Sinai

Miami Beach, Florida, 33140, United States

Location

NCH Rooney Heart Institute

Naples, Florida, 34102, United States

Location

AdventHealth Orlando

Orlando, Florida, 32803, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital and Emory University Hospital Midtown

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

St. Vincent Heart Center

Carmel, Indiana, 46290, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Woman's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

St.Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Washington University/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Morristown Medical Center

Morristown, New Jersey, 07960, United States

Location

Rutgers-RWJMS

New Brunswick, New Jersey, 08901, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

State University of New York at Buffalo

Buffalo, New York, 14203, United States

Location

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Lenox Hill Hospital and North Shore University

New York, New York, 10075, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219-2906, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Cardiovascular

Oklahoma City, Oklahoma, 73120, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg

Wormleysburg, Pennsylvania, 17043, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

WellSpan York Hospital

York, Pennsylvania, 17405, United States

Location

CVA Heart Institute Kingsport

Kingsport, Tennessee, 37660, United States

Location

Baptist Memorial Hospital Memphis

Memphis, Tennessee, 38138, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Saint Thomas Heart at Saint Thomas West

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

St. Pauls Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval

Québec, G1V 4G5, Canada

Location

Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum

Bad Oeynhausen, 32545, Germany

Location

Herzzentrum Universitätsklinikum Koln

Cologne, 50937, Germany

Location

Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum

Essen, 45174, Germany

Location

Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie

Giessen, 35392, Germany

Location

Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie

Hamburg, 20246, Germany

Location

Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie

Heidelberg, 69120, Germany

Location

Herzzentrum Leipzig Universitätsklinik für Kardiologie

Leipzig, 04289, Germany

Location

Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, 55131, Germany

Location

Medizinische Klinik I LMU München Campus Grosshadern

München, 81377, Germany

Location

Helios Klinikum Siegburg

Siegburg, 53721, Germany

Location

ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II

Ulm, 89081, Germany

Location

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (3)

• Marcoff L, Koulogiannis K, Aldaia L, Mediratta A, Chadderdon SM, Makar MM, Ruf TF, Gossler T, Zaroff JG, Leung GK, Ku IA, Nabauer M, Grayburn PA, Wang Z, Hawthorne KM, Fowler DE, Dal-Bianco JP, Vannan MA, Bevilacqua C, Meineri M, Ender J, Forner AF, Puthumana JJ, Mansoor AH, Lloyd DJ, Voskanian SJ, Ghobrial A, Hahn RT, Mahmood F, Haeffele C, Ong G, Schneider LM, Wang DD, Sekaran NK, Koss E, Mehla P, Harb S, Miyasaka R, Ivannikova M, Stewart-Dehner T, Mitchel L, Raissi SR, Kalbacher D, Biswas S, Ho EC, Goldberg Y, Smith RL, Hausleiter J, Lim DS, Gillam LD; CLASP IID Pivotal Trial Investigators. Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Imaging. 2024 May;17(5):471-485. doi: 10.1016/j.jcmg.2023.09.015. Epub 2023 Dec 13.

  PMID: 38099912 DERIVED

• Hausleiter J, Lim DS, Gillam LD, Zahr F, Chadderdon S, Rassi AN, Makkar R, Goldman S, Rudolph V, Hermiller J, Kipperman RM, Dhoble A, Smalling R, Latib A, Kodali SK, Lazkani M, Choo J, Lurz P, O'Neill WW, Laham R, Rodes-Cabau J, Kar S, Schofer N, Whisenant B, Inglessis-Azuaje I, Baldus S, Kapadia S, Koulogiannis K, Marcoff L, Smith RL; PASCAL IID Registry Investigators. Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. J Am Coll Cardiol. 2023 Feb 7;81(5):431-442. doi: 10.1016/j.jacc.2022.11.034.

  PMID: 36725171 DERIVED

• Lim DS, Smith RL, Gillam LD, Zahr F, Chadderdon S, Makkar R, von Bardeleben RS, Kipperman RM, Rassi AN, Szerlip M, Goldman S, Inglessis-Azuaje I, Yadav P, Lurz P, Davidson CJ, Mumtaz M, Gada H, Kar S, Kodali SK, Laham R, Hiesinger W, Fam NP, Kessler M, O'Neill WW, Whisenant B, Kliger C, Kapadia S, Rudolph V, Choo J, Hermiller J, Morse MA, Schofer N, Gafoor S, Latib A, Koulogiannis K, Marcoff L, Hausleiter J; CLASP IID Pivotal Trial Investigators. Randomized Comparison of Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients. JACC Cardiovasc Interv. 2022 Dec 26;15(24):2523-2536. doi: 10.1016/j.jcin.2022.09.005. Epub 2022 Sep 17.

  PMID: 36121247 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Scott Lim, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Robert Smith, MD

  The Heart Hospital Baylor Plano

  PRINCIPAL INVESTIGATOR

• Linda Gillam, MD

  Morristown Medical Center

  PRINCIPAL INVESTIGATOR

• Vinod Thourani, MD

  Piedmont Healthcare

  PRINCIPAL INVESTIGATOR

• Paul Grayburn, MD

  The Heart Hospital Baylor Plano

  PRINCIPAL INVESTIGATOR

• Brian K Whisenant, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

• Jörg Hausleiter, MD

  LMU München, Campus Gorsshadern

  PRINCIPAL INVESTIGATOR

• Ralph Stephan von Bardeleben, MD

  / Universitätsmedizin Mainz- Zentrum für Kardiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 16, 2018
• Study Start: November 30, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2031
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5); CH (1); US (68); DE (12)