Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)
Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency
About this trial
This is an interventional treatment trial for Degenerative Mitral Valve Disease
Eligibility Criteria
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 BNP > 150 pg/ml or corrected NT-pro BNP of > 600 pg/ml or heart failure hospitalization within the past 12 months (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, 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)
- Active rheumatic heart disease or rheumatic etiology for MR
- Severe aortic stenosis or regurgitation
- Known history of untreated, severe carotid stenosis
- History of 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
Sites / Locations
- The University of Alabama at BirminghamRecruiting
- Banner University Medical CenterRecruiting
- Abrazo Arizona Heart HospitalRecruiting
- Arizona Cardiovascular Research CenterRecruiting
- TMC HealthcareRecruiting
- PIH Health Good Samaritan HospitalRecruiting
- Cedars Sinai Medical CenterRecruiting
- St. Joseph HospitalRecruiting
- Sutter Medical Center-SacramentoRecruiting
- UC Davis Medical Center
- Scripps Memorial Hospital La JollaRecruiting
- Sutter Bay Area
- Kaiser Permanente San FranciscoRecruiting
- Stanford UniversityRecruiting
- Los Robles Hospital and Medical CenterRecruiting
- University of Colorado Hospital
- Medical Center of the RockiesRecruiting
- Medstar Washington Hospital CenterRecruiting
- The Cardiac and Vascular Institute Research FoundationRecruiting
- Mount SinaiRecruiting
- NCH Healthcare System NaplesRecruiting
- AdventHealth OrlandoRecruiting
- Cleveland Clinic Florida
- Piedmont HealthcareRecruiting
- Emory University Hospital and Emory University Hospital MidtownRecruiting
- Northwestern UniversityRecruiting
- Advocate Health & Hospitals Corp/Edward Heart Hospital
- St. Vincent Heart CenterRecruiting
- University of Iowa Hospitals & ClinicsRecruiting
- Cardiovascular Research Institute of Kansas
- Oschner Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- Brigham and Woman's HospitalRecruiting
- Beth Israel Deaconess Medical CenterRecruiting
- University of MichiganRecruiting
- Henry Ford HospitalRecruiting
- Fairview Health Services
- Mayo ClinicRecruiting
- St.Luke's Hospital of Kansas CityRecruiting
- Washington University/Barnes Jewish HospitalRecruiting
- Morristown Medical CenterRecruiting
- Rutgers-RWJMSRecruiting
- Albany Medical CollegeRecruiting
- Montefiore Medical CenterRecruiting
- State University of New York at BuffaloRecruiting
- NYU Winthrop HospitalRecruiting
- NYU Langone HealthRecruiting
- Columbia University Medical Center/New York Presbyterian HospitalRecruiting
- Lenox Hill Hospital and North Shore UniversityRecruiting
- Rochester General HospitalRecruiting
- St. Francis HospitalRecruiting
- Atrium Health/Sanger Heart & Vascular InstituteRecruiting
- The Christ HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- The Ohio State University Medical CenterRecruiting
- OhioHealth Research Institute
- Integris Health Baptist Medical CenterRecruiting
- Oklahoma CardiovascularRecruiting
- Oklahoma Heart InstituteRecruiting
- Providence St. Vincent Medical Center
- Oregon Health & Science UniversityRecruiting
- Hospital of the University of Pennsylvania/Penn Presbyterian Medical CenterRecruiting
- Allegheny General Hospital
- Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle HarrisburgRecruiting
- Lankenau Medical CenterRecruiting
- Centennial Medical CenterRecruiting
- Saint Thomas Heart at Saint Thomas WestRecruiting
- Vanderbilt University Medical CenterRecruiting
- Medical City Dallas
- HCA Houston Healthcare Medical CenterRecruiting
- Baylor College of MedicineRecruiting
- Houston Methodist HospitalRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- The Heart Hospital Baylor PlanoRecruiting
- Intermountain Medical CenterRecruiting
- University of VirginiaRecruiting
- Sentara Norfolk General Hospital
- Chippenham Johnston & Willis Medical CenterRecruiting
- Swedish Medical CenterRecruiting
- University of WashingtonRecruiting
- Aurora St. Luke's Medical CenterRecruiting
- St. Pauls HospitalRecruiting
- St. Michael's HospitalRecruiting
- Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULavalRecruiting
- Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität BochumRecruiting
- Herzzentrum Universitätsklinikum KolnRecruiting
- Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität DresdenRecruiting
- Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und GefäßzentrumRecruiting
- Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ KardiologieRecruiting
- Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle KardiologieRecruiting
- Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, PneumologieRecruiting
- Herzzentrum Leipzig Universitätsklinik für KardiologieRecruiting
- Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität MainzRecruiting
- Medizinische Klinik I LMU München Campus GrosshadernRecruiting
- Helios Klinikum SiegburgRecruiting
- ULM University Zentrum für Innere Medizin Klinik für Innere Medizin IIRecruiting
- University Hospital BernRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Edwards PASCAL System - CLASP IID
Abbott Mitraclip System - CLASP IID
Edwards PASCAL System - CLASP IIF
Abbott Mitraclip System - CLASP IIF
Edwards PASCAL System - Single-Arm Registry
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
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.