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

Status: Recruiting
Location: See all (61) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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, Belgium 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
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Adult patients ≥60 yrs 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 MV transcatheter edge-to-edge and surgical repair per local heart team assessment

• Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on the local heart team assessment (see 2020 ACC/AHA guidelines for the management of patients with valvular heart disease)

• Patients with AF who meet an indication for concomitant ablation may be included provided the local heart team verifies 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

Locations
United States
California
Cedars Sinai Medical Center
RECRUITING
Los Angeles
Keck Hospital of the University of Southern California
RECRUITING
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Stanford University
RECRUITING
Stanford
Georgia
Emory University
RECRUITING
Atlanta
Piedmont Heart Institute
RECRUITING
Atlanta
Louisiana
Ochsner Clinic
RECRUITING
New Orleans
Massachusetts
Brigham and Women's
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
The Johns Hopkins Hospital
RECRUITING
Baltimore
Maine
Maine Medical Center
RECRUITING
Portland
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Missouri
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
RECRUITING
Kansas City
North Carolina
Duke University Hospital
RECRUITING
Durham
New Hampshire
Dartmouth Hitchcock Medical Center
RECRUITING
Lebanon
New York
Northwell Health
RECRUITING
New York
Nyph/Cumc
RECRUITING
New York
Weill Cornell Medicine/ New York-Presbyterian Hospital
RECRUITING
New York
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
Baylor, Scott and White
RECRUITING
Dallas
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
West Virginia
West Virginia University Hospital
RECRUITING
Morgantown
Other Locations
Canada
London Health Sciences
RECRUITING
London
University of Ottawa Heart Institute
RECRUITING
Ottawa
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)
RECRUITING
Québec
Unity Health Toronto (St. Michael's Hospital)
RECRUITING
Toronto
University of British Columbia, Providence Health Care, St. Paul's Hospital
RECRUITING
Vancouver
Germany
Kerckhoff Klinik Bad Nauheim
RECRUITING
Bad Nauheim
Herz- und Diabeteszentrum NRW
RECRUITING
Bad Oeynhausen
Schüchtermann-Klinik Bad Rothenfelde
RECRUITING
Bad Rothenfelde
Deutsches Herzzentrum der Charité
RECRUITING
Berlin
Universitätsklinikum Köln
RECRUITING
Cologne
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt
Universitätsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Asklepios Klinik St. Georg Hamburg
RECRUITING
Hamburg
Universitätsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsklinikum Schleswig-Holstein Campus Kiel
RECRUITING
Kiel
Herzzentrum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Schleswig-Holstein Campus Lübeck
RECRUITING
Lübeck
Deutsches Herzzentrum München
RECRUITING
München
Spain
Hospital Clinic De Barcelona
RECRUITING
Barcelona
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Central de Asturias
RECRUITING
Oviedo
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Royal Papworth Hospital NHS Foundation Trust
RECRUITING
Cambridge
Golden Jubilee University National Hospital
RECRUITING
Clydebank
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Headington
The Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
Barts Health NHS Trust
RECRUITING
London
King's College Hospital NHS Foundation Trust
RECRUITING
London
Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
St. Thomas Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Manchester University NHS Foundation Trust
RECRUITING
Manchester
South Tees Hospital NHS Foundation Trust
RECRUITING
Middlesbrough
South Tees Hospitals NHS Foundation Trust
RECRUITING
Middlesbrough
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Worthing
Contact Information
Primary
Chari Ponder, RN, BSN
chari.ponder@mountsinai.org
(646) 899-8106
Time Frame
Start Date: 2022-02-21
Estimated Completion Date: 2030-11-15
Participants
Target number of participants: 450
Treatments
Active_comparator: Surgical mitral valve repair
Patients who are randomized to the surgical arm will undergo mitral surgery.
Active_comparator: Transcatheter edge-to-edge repair
In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Authors
Tom Nguyen, Isaac George, Kenan Yount, Gorav Ailawadi, Joanna Chikwe
Related Therapeutic Areas
Mitral Valve Regurgitation
Sponsors
Leads: Annetine Gelijns
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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