An interventional study of Cardiac Magnetic Resonance Imaging and ZioPatch Monitoring in Mitral Valve Prolapse, Left Ventricular Fibrosis and Ventricular Arrhythmias, sponsored by Annetine Gelijns. Active, not recruiting at 25 sites in 3 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Annetine Gelijns · Not applicable, Interventional, and Basic science
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.
This is an ancillary study of a multicenter randomized clinical trial comparing MVr to TEER for degenerative mitral regurgitation (MR) involving up to 250 patients from the parent trial. All patients will receive rhythm monitoring, up to 200 patients will receive pre/post intervention CMR, all patients in the parent trial will undergo a transthoracic echocardiogram (TTE) (as part of the randomized controlled trial (RCT)), and 60 surgical patients will undergo tissue biopsies. The study is being conducted in highly experienced clinical centers in the U.S., Canada, Germany, the U.K. and Spain. The estimated enrollment period is 12-18 months. Outcomes will be measured from baseline to 12 months after randomization.
This mechanistic ancillary study has the following aims:
41 studies on the registry are indexed under Mitral Valve Prolapse; 13 are open to participants now.
This study's planned enrollment of 250 is above the median of 40 across 18 interventional studies indexed under Mitral Valve Prolapse.
Browse Mitral Valve Prolapse studies →Annetine Gelijns is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mitral 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.
Procedure: Cardiac Magnetic Resonance Imaging · Device: ZioPatch Monitoring · Procedure: Myocardial Tissue Biopsy
Patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Procedure: Cardiac Magnetic Resonance Imaging · Device: ZioPatch Monitoring
Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation.
Also known as: CMR
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.
Also known as: iRhythm Monitoring
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.
Also known as: Heart Bioplsy
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year post index procedure.
Computational and Predictive Models of Treatment Outcome
specific treatment. These tools help doctors make more personalized and effective care decisions based on patterns found in large sets of medical information.
Time frame: 1 year post index procedure.
Plan to share: No — Data shared will be in aggregate.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Annetine Gelijns