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RECRUITING

NCT05051033

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

Sponsor: Annetine Gelijns

View on ClinicalTrials.gov

Summary

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2022-02-21

Completion Date

2030-11-15

Last Updated

2026-03-03

Healthy Volunteers

Conditions

Mitral Valve Regurgitation

Interventions

PROCEDURE

Mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.

DEVICE

Transcatheter edge-to-edge repair

Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.

The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity. Inclusion Criteria: * Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography * Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification * Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC/AHA 2020 guidelines for the management of patients with valvular heart disease) * Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation. * Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument Exclusion Criteria: * Non-degenerative types of primary MR (e.g., cleft leaflet) * Secondary or functional MR * Hypertrophic obstructive cardiomyopathy * Presence of an IVC filter or permanent pacing/ICD leads that would interfere with TEER per local heart team assessment * Known allergic reactions to intravenous contrast * Febrile illness within 30-days prior to randomization * Any absolute contraindication to transesophageal echocardiography * Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia * Patients with CAD requiring revascularization * Any prior mitral valve intervention or any prior repair of atrial septal defect * Any prior MV intervention or any prior repair of atrial septal defect * Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery * Need for any emergency intervention or surgery * Active endocarditis * Hemodynamic instability defined as cardiac index \<2.0 l/min/m2 or systolic blood pressure \<90mmHg or need for inotropic support or any mechanical circulatory support * Left ventricular ejection fraction \<25% * Intracardiac mass or thrombus * Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely * Active substance abuse * Suspected inability to adhere to follow-up * Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.

Locations (61)

Keck Hospital of the University of Southern California

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Emory University

Atlanta, Georgia, United States

Ochsner Clinic

New Orleans, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham and Women's

Boston, Massachusetts, United States

University of Michigan Hospital

Ann Arbor, Michigan, United States

Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons

Kansas City, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

New York-Presbyterian/Columbia University Medical Center

New York, New York, United States

Weill Cornell Medicine/ New York-Presbyterian Hospital

New York, New York, United States

Northwell Health

New York, New York, United States

Duke University Hospital

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Baylor, Scott and White

Dallas, Texas, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

West Virginia University Hospital

Morgantown, West Virginia, United States

University of British Columbia, Providence Health Care, St. Paul's Hospital

Vancouver, British Columbia, Canada

London Health Sciences

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Unity Health Toronto (St. Michael's Hospital)

Toronto, Ontario, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)

Québec, Quebec, Canada

Universitätsklinikum Köln

Cologne, Berlin-kölnische Allee, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Kerckhoff Klinik Bad Nauheim

Bad Nauheim, Germany

Schüchtermann-Klinik Bad Rothenfelde

Bad Rothenfelde, Germany

Deutsches Herzzentrum der Charité

Berlin, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Asklepios Klinik St. Georg Hamburg

Hamburg, Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Universitätsklinikum Heidelberg

Heidelberg, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Herzzentrum Leipzig

Leipzig, Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Germany

Deutsches Herzzentrum München

München, Germany

Hospital Alvaro Cunqueiro

Vigo, Galacia, Spain

Hospital Clinic De Barcelona

Barcelona, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Central de Asturias

Oviedo, Spain

Royal Papworth Hospital NHS Foundation Trust

Cambridge, England, United Kingdom

The Leeds Teaching Hospitals NHS Trust

Leeds, England, United Kingdom

St. Thomas Guy's and St Thomas' NHS Foundation Trust

London, England, United Kingdom

King's College Hospital NHS Foundation Trust

London, England, United Kingdom

Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust

London, England, United Kingdom

Manchester University NHS Foundation Trust

Manchester, England, United Kingdom

University Hospitals Sussex NHS Foundation Trust

Worthing, West Sussex, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Golden Jubilee University National Hospital

Clydebank, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Headington, United Kingdom

Barts Health NHS Trust

London, United Kingdom

South Tees Hospitals NHS Foundation Trust

Middlesbrough, United Kingdom

South Tees Hospital NHS Foundation Trust

Middlesbrough, United Kingdom

Clinical Research Directory

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (61)