Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy
Annetine Gelijns
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.
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 will receive rhythm monitoring, up to 200 patients will receive pre/post intervention CMR, all patients in the parent trial will undergo a transthoracic echocardiogram (TTE) (as part of the randomized controlled trial (RCT)), and 60 surgical patients will undergo tissue biopsies. The study is being conducted in highly experienced clinical centers in the U.S., Canada, Germany, the U.K. and Spain. T…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- ProcedureCardiac Magnetic Resonance Imaging
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
- DeviceZioPatch Monitoring
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.
- ProcedureMyocardial Tissue Biopsy
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)
- Keck Hospital of the University of Southern CaliforniaLos Angeles, California
- Cedars-SinaiLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Stanford UniversityStanford, California
- Piedmont Heart InstituteAtlanta, Georgia
- Maine Medical CenterPortland, Maine