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

Description

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 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.

Conditions

Mitral Valve Regurgitation

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Study Overview

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Study Details

Study overview

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 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.

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

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

Condition
Mitral Valve Regurgitation
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Keck Hospital of the University of Southern California, Los Angeles, California, United States, 90033

Los Angeles

Cedars Sinai Medical Center, Los Angeles, California, United States, 90048

San Francisco

University of California San Francisco, San Francisco, California, United States, 94143

Stanford

Stanford University, Stanford, California, United States, 94305

Atlanta

Piedmont Heart Institute, Atlanta, Georgia, United States, 30309

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

New Orleans

Ochsner Clinic, New Orleans, Louisiana, United States, 70121

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Baltimore

The Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adult patients ≥65 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
  • * Non-degenerative types of primary MR (e.g., cleft leaflet)
  • * Secondary or functional MR
  • * Hypertrophic obstructive cardiomyopathy
  • * Presence of an IVC filter or 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 meaningful 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 its primary endpoint or that clinically interferes with the present study endpoints.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Annetine Gelijns,

Joann Chikwe, MD, STUDY_DIRECTOR, Cedars Sinai

Martin Leon, MD, STUDY_DIRECTOR, Columbia University

Patrick O'Gara, MD, STUDY_DIRECTOR, Brigham and Women's Hospital

Study Record Dates

2032-01