PRIMARY Ancillary Substudy

Recruiting now · Not applicable

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

In brief

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.

Key facts

Study ID

NCT07103733

Run by

Annetine Gelijns

People needed

250

Starts

2023-10-16

Expected to finish

2027-06-30

Last updated by the study team

2025-08-19

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Keck Hospital of the University of Southern California — Los Angeles, California, United States (enrolling)
• Cedars-Sinai — Los Angeles, California, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• Stanford University — Stanford, California, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Maine Medical Center — Portland, Maine, United States (enrolling)
• The Johns Hopkins Hospital — Baltimore, Maryland, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan Hospital — Ann Arbor, Michigan, United States (enrolling)
• Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons — Kansas City, Missouri, United States (enrolling)
• Weill Cornell Medicine/ New York-Presbyterian Hospital — New York, New York, United States (enrolling)
• Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital — New York, New York, United States (enrolling)
• Duke University Hospital — Durham, North Carolina, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• University of Virginia Medical Center — Charlottesville, Virginia, United States (enrolling)
• West Virginia University Hospital — Morgantown, West Virginia, United States (enrolling)
• Deutsches Herzzentrum der Charité — Berlin, Germany (enrolling)
• Herzzentrum Leipzig — Leipzig, Germany (enrolling)
• Royal Papworth Hospital NHS Foundation Trust — Trumpington, Cambridge, United Kingdom (enrolling)
• The Leeds Teaching Hospitals NHS Trust — Leeds, England, United Kingdom (enrolling)
• Barts Health NHS Trust — Whitechapel, London, United Kingdom (enrolling)
• Manchester University NHS Foundation Trust — Oxford, Manchester, United Kingdom (enrolling)
• South Tees Hospitals NHS Foundation Trust — Marton-in-Cleveland, Middlesbrough, United Kingdom (enrolling)
• Oxford University Hospitals NHS Foundation Trust — Oxford, Oxfordshire, United Kingdom (enrolling)
• University Hospitals Sussex NHS Foundation Trust — Worthing, West Sussex, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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