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PRIMARY Ancillary Substudy

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Enrollment closed, study ongoing
    • Site details revised at 25 of 25 sites
    v3
  2. Minor Study Status, Referencesv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07103733
Lead Sponsor Annetine Gelijns
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Mitral Valve Prolapse, Left Ventricular Fibrosis, Ventricular Arrhythmias
Related terms Mitral Valve Prolapse
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov