PRIMARY Ancillary Substudy
Recruiting
N/A
Interventional Study
Mitral Valve Prolapse
Left Ventricular Fibrosis
Ventricular Arrhythmias
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 60 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Basic Science
- Participants needed
- 250 (estimated)
- Sponsor
- Annetine Gelijns · Other
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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. S…
Trial Locations
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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…
Contacts