PRIMARY Ancillary Substudy

Launched by ANNETINE GELIJNS · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two ways to treat a heart condition called mitral valve prolapse, where a valve in the heart doesn’t close properly. The trial compares traditional mitral valve repair surgery to a less invasive procedure called transcatheter-edge-to-edge repair (TEER). The goal is to understand how mitral valve prolapse affects the heart’s muscle and rhythm, which can sometimes lead to serious problems like irregular heartbeats or heart failure. By learning more about these effects, doctors hope to find better treatments and prevent complications in different groups of patients.

To take part, patients must already be enrolled in the main PRIMARY trial and specifically be assigned to have the mitral valve repair surgery. Some people won’t be able to join, such as those who have severe claustrophobia that can’t be managed, allergies to certain dyes used in heart scans, or certain implanted heart devices that interfere with MRI imaging. Participants can expect to have tests like heart scans and rhythm monitoring to help researchers see how the heart is working after treatment. This study is currently recruiting, and it includes adults of all genders who meet the criteria.

Gender

ALL

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).