Status:

RECRUITING

PRIMARY Ancillary Substudy

Lead Sponsor:

Annetine Gelijns

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Mitral Valve Prolapse

Left Ventricular Fibrosis

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

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 in...

Detailed Description

This is an ancillary study of a multicenter randomized clinical trial comparing MVr to TEER for degenerative mitral regurgitation (MR) involving up to 250 patients from the parent trial. All patients ...

Eligibility Criteria

Inclusion 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.

Exclusion Criteria:

  • 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).

Key Trial Info

Start Date :

October 16 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT07103733

Start Date

October 16 2023

End Date

June 30 2027

Last Update

August 19 2025

Active Locations (25)

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Page 1 of 7 (25 locations)

1

Keck Hospital of the University of Southern California

Los Angeles, California, United States, 90033

2

Cedars-Sinai

Los Angeles, California, United States, 90048

3

University of California San Francisco

San Francisco, California, United States, 94143

4

Stanford University

Stanford, California, United States, 94305