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PRIMARY Ancillary Substudy
PRIMARY Ancillary Substudy

NCT07103733

Active Not RecruitingNA

Sponsor: Annetine Gelijns

Conditions: Mitral Valve Prolapse, Left Ventricular Fibrosis, Ventricular Arrhythmias

Interventions: Cardiac Magnetic Resonance Imaging, ZioPatch Monitoring, Myocardial Tissue Biopsy

Countries: United States, Germany, United Kingdom

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 overview

Sex: ALL

Age: 60 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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).
Locations (25)
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • San Francisco, California, United States
  • Stanford, California, United States
  • Atlanta, Georgia, United States
  • Portland, Maine, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Kansas City, Missouri, United States
  • New York, New York, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Charlottesville, Virginia, United States
  • Morgantown, West Virginia, United States
  • Berlin, Germany
  • Leipzig, Germany
  • Trumpington, Cambridge, United Kingdom
  • Leeds, England, United Kingdom
  • Whitechapel, London, United Kingdom
  • Oxford, Manchester, United Kingdom
  • Marton-in-Cleveland, Middlesbrough, United Kingdom
  • Oxford, Oxfordshire, United Kingdom
  • Worthing, West Sussex, United Kingdom