PRIMARY Ancillary Substudy

NCT07103733 · tracked via the Priya Life Science Germany tracker

Sponsor

Annetine Gelijns

Phase

Not applicable

Started

2023-10-16

Last updated

2026-09-08

Condition(s) studied

Mitral Valve ProlapseLeft Ventricular FibrosisVentricular Arrhythmias

Investigational drug(s) / intervention(s)

Cardiac Magnetic Resonance ImagingZioPatch MonitoringMyocardial Tissue Biopsy

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.

Study 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.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

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).

Primary outcome measure(s)

Presence of Myocardial Fibrosis — 1 year post index procedure.
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.
Presence of Ventricular Arrythmia — 1 year post index procedure.
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.
Proteomics — 1 year post index procedure.
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.

Trial sites (25)

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

More Annetine Gelijns trials in Germany

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY) Active, not recruiting

Other trials for the same condition

Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07103733 on ClinicalTrials.gov ↗ ← All trials in Germany