PRIMARY Ancillary Substudy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorAnnetine Gelijns
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Cardiac Magnetic Resonance Imaging
- ZioPatch Monitoring
- Myocardial Tissue Biopsy
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Annetine Gelijns
Lead sponsor
Icahn School of Medicine at Mount Sinai
Sponsor institution
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov