PRIMARY Ancillary Substudy
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Ancillary Substudy
2 other identifiers
interventional
250
3 countries
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2023
CompletedFirst Submitted
Initial submission to the registry
July 22, 2025
CompletedFirst Posted
Study publicly available on registry
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
August 19, 2025
August 1, 2025
3.7 years
July 22, 2025
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
Secondary Outcomes (1)
Computational and Predictive Models of Treatment Outcome
1 year post index procedure.
Study Arms (2)
Mitral valve repair
ACTIVE COMPARATORMitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance.
Transcatheter edge-to-edge repair
ACTIVE COMPARATORPatients will be treated with a commercially-approved edge-to-edge mitral repair device.
Interventions
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
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.
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.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Keck Hospital of the University of Southern California
Los Angeles, California, 90033, United States
Cedars-Sinai
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94143, United States
Stanford University
Stanford, California, 94305, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Maine Medical Center
Portland, Maine, 04102, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Kansas City, Missouri, 64111, United States
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, 10065, United States
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
New York, New York, 10075, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
West Virginia University Hospital
Morgantown, West Virginia, 26506, United States
Deutsches Herzzentrum der Charité
Berlin, 13353, Germany
Herzzentrum Leipzig
Leipzig, 04289, Germany
Royal Papworth Hospital NHS Foundation Trust
Trumpington, Cambridge, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, England, LS9 7TF, 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, OX3 9DU, United Kingdom
University Hospitals Sussex NHS Foundation Trust
Worthing, West Sussex, BN11 2DH, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joanna Chikwe, MD
Cedars-Sinai
- STUDY DIRECTOR
Martin Leon, MD
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The PRIMARY trial is an open-label trial. As in the parent trial, clinical investigators, and coordinators, however, will be blinded to all overall outcome data in the ancillary study.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Department Chair, Department of Population Health Science & Policy Edmond A. Guggenheim Professor of Health Policy Co-Director, InCHOIR
Study Record Dates
First Submitted
July 22, 2025
First Posted
August 5, 2025
Study Start
October 16, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Data shared will be in aggregate.