Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1247 participants
INTERVENTIONAL
2018-11-30
2031-06-30
Brief Summary
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Detailed Description
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Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Edwards PASCAL System - CLASP IID
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System - CLASP IID
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Edwards PASCAL System - CLASP IIF
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System - CLASP IIF
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Edwards PASCAL System - Single-Arm Registry
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.
Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Interventions
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Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Lim, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Robert Smith, MD
Role: PRINCIPAL_INVESTIGATOR
The Heart Hospital Baylor Plano
Linda Gillam, MD
Role: PRINCIPAL_INVESTIGATOR
Morristown Medical Center
Vinod Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Healthcare
Paul Grayburn, MD
Role: PRINCIPAL_INVESTIGATOR
The Heart Hospital Baylor Plano
Brian K Whisenant, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Jörg Hausleiter, MD
Role: PRINCIPAL_INVESTIGATOR
LMU München, Campus Gorsshadern
Ralph Stephan von Bardeleben, MD
Role: PRINCIPAL_INVESTIGATOR
/ Universitätsmedizin Mainz- Zentrum für Kardiologie
Locations
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Banner University Medical Center
Phoenix, Arizona, United States
Abrazo Arizona Heart Hospital
Phoenix, Arizona, United States
TMC Healthcare
Tucson, Arizona, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
UC Irvine
Orange, California, United States
Sutter Medical Center-Sacramento
Sacramento, California, United States
Sutter Bay Area
San Francisco, California, United States
Kaiser Permanente San Francisco
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Medical Center of the Rockies
Loveland, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
The Cardiac and Vascular Institute Research Foundation
Gainesville, Florida, United States
Mount Sinai
Miami Beach, Florida, United States
NCH Healthcare System Naples
Naples, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory University Hospital and Emory University Hospital Midtown
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
St. Vincent Heart Center
Carmel, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota, United States
St.Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Washington University/Barnes Jewish Hospital
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Rutgers-RWJMS
New Brunswick, New Jersey, United States
Albany Medical College
Albany, New York, United States
State University of New York at Buffalo
Buffalo, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
NYU Langone Health
New York, New York, 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
Rochester General Hospital
Rochester, New York, United States
St. Francis Hospital
Roslyn, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oklahoma Cardiovascular
Oklahoma City, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg
Wormleysburg, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
WellSpan York Hospital
York, Pennsylvania, United States
CVA Heart Institute Kingsport
Kingsport, Tennessee, United States
Baptist Memorial Hospital Memphis
Memphis, Tennessee, 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
HCA Houston Healthcare Medical Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
St. Pauls Hospital
Vancouver, British Columbia, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval
Québec, , Canada
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, , Germany
University Hospital Bern
Bern, , Switzerland
Countries
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References
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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.
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.
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.
Other Identifiers
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2018-07
Identifier Type: -
Identifier Source: org_study_id
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