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PRIMARY Ancillary Substudy
Sponsor: 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.
Official title: Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2023-10-16
Completion Date
2027-06-30
Last Updated
2025-08-19
Healthy Volunteers
No
Interventions
Cardiac Magnetic Resonance Imaging
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
ZioPatch 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.
Myocardial 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 California
Los Angeles, California, United States
Cedars-Sinai
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Maine Medical Center
Portland, Maine, United States
The Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, United States
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, United States
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
New York, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
West Virginia University Hospital
Morgantown, West Virginia, United States
Deutsches Herzzentrum der Charité
Berlin, Germany
Herzzentrum Leipzig
Leipzig, Germany
Royal Papworth Hospital NHS Foundation Trust
Trumpington, Cambridge, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, England, United Kingdom
Barts Health NHS Trust
Whitechapel, London, United Kingdom
Manchester University NHS Foundation Trust
Oxford, Manchester, United Kingdom
South Tees Hospitals NHS Foundation Trust
Marton-in-Cleveland, Middlesbrough, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, West Sussex, United Kingdom