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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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