PRIMARY Ancillary Substudy
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy
Annetine Gelijns
250 participants
Oct 16, 2023
INTERVENTIONAL
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 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
Inclusion Criteria2
- 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 Criteria4
- 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).
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Interventions
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch is a small, wearable heart monitor that sticks to the chest and records the heart's electrical activity continuously for up to 14 days. It helps doctors detect irregular heart rhythms (arrhythmias) without the need for bulky wires or equipment.
During the MVr procedure, surgeons will biopsy approximately 50 μg of tissue from the endocardial and subendocardial myocardium in the inferobasilar and control areas using a surgical rongeur.
Locations(25)
View Full Details on ClinicalTrials.gov
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NCT07103733