RECRUITING

PRIMARY Ancillary Substudy

Description

The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.

Conditions

Mitral Valve ProlapseLeft Ventricular FibrosisVentricular Arrhythmias
Talk to us

Related Conditions:

Mitral Valve ProlapseLeft Ventricular FibrosisVentricular Arrhythmias

Study Overview

On this page

Study Details

Study overview

The PRIMARY trial (NCT05051033), which compares mitral valve repair (MVr) to transcatheter-edge-to-edge-repair (TEER), offers a platform for conducting mechanistic studies to develop early insights into the pathophysiological processes by which mitral valve prolapse (MVP) can impact left ventricular (LV) myocardial structure and function, and, thereby, predispose to arrhythmias and sudden death. Such insights are key to identifying interventions to reduce the long-term sequelae of heart failure (HF) and arrhythmias, as well as delineate optimal therapeutic approaches for different patient sub-groups.

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

PRIMARY Ancillary Substudy

Condition
Mitral Valve Prolapse
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, 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

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

Ann Arbor

University of Michigan Hospital, Ann Arbor, Michigan, United States, 48109

Kansas City

Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons, Kansas City, Missouri, United States, 64111

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

  • * Patients who meet all eligibility criteria and are randomized in the parent PRIMARY trial.
  • * For the ancillary biospecimen study, patients who are randomized to MVr in the parent trial.
  • * Severe claustrophobia not controlled with sedation.
  • * Prior adverse reaction to gadolinium administration.
  • * Patients with an implantable subcutaneous cardioverter defibrillator and/or cardiac resynchronization therapy device with defibrillator may be excluded as they typically produce substantial artifacts on cardiac MRI making assessment very challenging.
  • * Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients undergoing rhythm monitoring).

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Annetine Gelijns,

Joanna Chikwe, MD, STUDY_DIRECTOR, Cedars-Sinai

Martin Leon, MD, STUDY_DIRECTOR, Columbia University

Study Record Dates

2027-06-30