PRIMARY Ancillary Substudy
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 250
- Expected completion
- 2027-06-30
- Funded by
- other
Conditions studied
Left Ventricular Fibrosis, Mitral Valve Prolapse, Ventricular Arrhythmias
What is being tested
- DEVICE: ZioPatch Monitoring
- PROCEDURE: Cardiac Magnetic Resonance Imaging
- PROCEDURE: Myocardial Tissue Biopsy
What it measures
- Presence of Myocardial Fibrosis, Myocardial fibrosis is the buildup of excess fibrous connective tissue in the heart muscle often resulting from chronic injury or stress. It can impair the heart's ability to contract and relax properly leading to reduced cardiac function., 1 year post index procedure.
- Presence of Ventricular Arrythmia, A ventricular arrhythmia is an abnormal heart rhythm that starts in the lower chambers of the heart (the ventricles). It can cause the heart to beat too fast, which may reduce blood flow to the body and, in some cases, be life-threatening., 1 year post index procedure.
- Proteomics, Proteomics is the large-scale study of proteins, which are essential molecules that carry out most functions in the body. By analyzing proteins in tissues or fluids, scientists can better understand diseases, identify biomarkers, and discover new treatment targets., 1 year post index procedure.
Working with
National Heart, Lung, and Blood Institute (NHLBI)
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Cedars-Sinai Medical Center
Los Angeles, CA
Cleveland Clinic
Cleveland, OH
Duke University Hospital
Durham, NC
J.W. Ruby Memorial Hospital
Morgantown, WV
Keck Hospital of USC
Los Angeles, CA
Lenox Hill Hospital
New York, NY
MaineHealth Maine Medical Center (Portland)
Portland, ME
Massachusetts General Hospital
Boston, MA
NewYork-Presbyterian Hospital
New York, NY
Piedmont Atlanta Hospital
Atlanta, GA
Saint Luke’s Hospital of Kansas City
Kansas City, MO
Stanford Health Care
Stanford, CA
The Johns Hopkins Hospital
Baltimore, MD
UCSF Health
San Francisco, CA
University Medical Center
Charlottesville, VA
University of Michigan Health System
Ann Arbor, MI
Registry entry updated 2026-09-08
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.