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Clinical Trials in Canada / NCT05051033
Active, not recruiting Not applicable

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

NCT05051033 · tracked via the Priya Life Science Canada tracker
Sponsor
Annetine Gelijns
Phase
Not applicable
Started
2022-02-21
Last updated
2026-09-10

Condition(s) studied

Mitral Valve Regurgitation

Investigational drug(s) / intervention(s)

Mitral valve repairTranscatheter edge-to-edge repair

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (62)

FacilityCityRegionStatus
Keck Hospital of the University of Southern California Los Angeles California
Cedars Sinai Medical Center Los Angeles California
University of California San Francisco San Francisco California
Stanford University Stanford California
Piedmont Heart Institute Atlanta Georgia
Emory University Atlanta Georgia
Ochsner Clinic New Orleans Louisiana
Maine Medical Center Portland Maine
The Johns Hopkins Hospital Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Boston Massachusetts
University of Michigan Hospital Ann Arbor Michigan
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons Kansas City Missouri
Dartmouth Hitchcock Medical Center Lebanon New Hampshire
New York-Presbyterian/Columbia University Medical Center New York New York
Weill Cornell Medicine/ New York-Presbyterian Hospital New York New York
Northwell Health New York New York
Duke University Hospital Durham North Carolina
Cleveland Clinic Cleveland Ohio
Hospital of the University of Pennsylvania Philadelphia Pennsylvania
Medical University of South Carolina Charleston South Carolina
Baylor, Scott and White Dallas Texas
University of Virginia Medical Center Charlottesville Virginia
West Virginia University Hospital Morgantown West Virginia
University of British Columbia, Providence Health Care, St. Paul's Hospital Vancouver British Columbia
London Health Sciences London Ontario
University of Ottawa Heart Institute Ottawa Ontario
Unity Health Toronto (St. Michael's Hospital) Toronto Ontario
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University) Québec Quebec
Universitätsklinikum Köln Cologne Berlin-kölnische Allee
Herz- und Diabeteszentrum NRW Bad Oeynhausen North Rhine-Westphalia
Universitätsklinikum Köln Cologne North Rhine-Westphalia
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

+ 22 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05051033 on ClinicalTrials.gov ↗ ← All trials in Canada