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PRIMARY ancillary: how mitral valve repair methods affect the heart

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

Not applicable Interventional Icahn School of Medicine at Mount Sinai · NCT07103733

This study will test whether surgical mitral valve repair or transcatheter edge‑to‑edge repair better improves heart muscle structure and reduces arrhythmias in people with mitral valve prolapse and degenerative mitral regurgitation.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages60 Years and up
SexAll
SponsorIcahn School of Medicine at Mount Sinai Academic / other
Locations25 sites (Los Angeles, California and 24 other locations)
Trial IDNCT07103733 on ClinicalTrials.gov

What this trial studies

This ancillary study enrolls up to 250 participants drawn from the multicenter PRIMARY randomized comparison of surgical mitral valve repair (MVr) versus transcatheter edge‑to‑edge repair (TEER) for degenerative mitral regurgitation. All participants receive rhythm monitoring and transthoracic echocardiography, up to 200 will have paired pre‑ and post‑procedure cardiac MRI, and about 60 surgical patients will undergo myocardial tissue biopsy. Investigators will use speckle tracking strain echocardiography, CMR measures of fibrosis, and continuous rhythm monitoring to compare changes in ventricular mechanics, fibrosis, and ventricular arrhythmia burden from baseline to 12 months. The work is performed at experienced academic centers in the U.S., Canada, Germany, the U.K., and Spain.

Who should consider this trial

Good fit: Ideal candidates are adults enrolled and randomized in the parent PRIMARY trial for degenerative mitral regurgitation due to mitral valve prolapse, with surgical patients eligible for the biopsy subcohort.

Not a fit: Patients who cannot undergo cardiac MRI (for example due to severe claustrophobia, gadolinium contraindication, or MRI‑incompatible devices) or who are not enrolled in the parent trial are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, the study could identify which repair approach better limits myocardial fibrosis and arrhythmias, helping clinicians choose treatments that reduce heart failure and sudden death risk.

How similar studies have performed: Prior imaging and observational studies have linked more durable surgical repair with improved remodeling and fewer arrhythmias, but randomized mechanistic comparisons of MVr versus TEER are limited, so this ancillary work is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Los Angeles, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral Valve ProlapseLeft Ventricular FibrosisVentricular ArrhythmiasMitral valve repairTranscatheter-edge-to-edge-repairCardiac magnetic resonance imagingZioPatch monitoringHeart biopsy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.