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

Running, not enrolling · Not applicable

Conditions studied: Mitral Valve Regurgitation

In brief

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 facts

Study ID

NCT05051033

Run by

Annetine Gelijns

People needed

450

Starts

2022-02-21

Expected to finish

2030-11-15

Last updated by the study team

2026-06-24

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Keck Hospital of the University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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