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PRIMARY Ancillary Substudy

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Cardiac Magnetic Resonance Imaging (procedure), ZioPatch Monitoring (device), Myocardial Tissue Biopsy (procedure)
How long the study runs: Study runs about 44 months (dates as stated)
About the drug or intervention: Cardiac Magnetic Resonance Imaging — procedure: Non-invasive imaging test that uses powerful magnets and radio waves to create detailed pictures of the heart without using radiation. · ZioPatch Monitoring — device: 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. · Myocardial Tissue Biopsy — procedure: 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.
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 60 Years and over
Who: All
Number of participants: 250
Started: 2023-10-16
Last checked: 2026-09

Plain English Summary

What is this study?

• Testing a new treatment for mitral valve prolapse
• NA - 250 participants
• 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

Who can take part?

• Ages 60 Years and over
• Diagnosed with mitral valve prolapse

Where?

• Trumpington - Royal Papworth Hospital NHS Foundation Trust
• Leeds - The Leeds Teaching Hospitals NHS Trust
• Whitechapel - Barts Health NHS Trust
• Oxford - Manchester University NHS Foundation Trust
• +3 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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: 1. To compare the impact of MVr and TEER on disordered ventricular biomechanics and myocardial fibrosis that predispose to ventricular arrhythmias, using speckle tracking strain echocardiography, cardiac magnetic resonance imaging (CMR), and rhythm monitoring pre- and post-mitral valve (MV) intervention. The research team hypothesize's that a treatment strategy that more effectively and durably reduces MVP and MR will lead to improved ventricular mechanics, limit progression of myocardial fibrosis and decrease the burden of ventricular arrhythmias and HF. 2. To compare the impact of MVr and TEER on recurrent/residual MR, LV and left atrial (LA) reverse remodeling with baseline and 1-year post-intervention CMR, and to use quantitative CMR myocardial tissue phenotyping as a predictor of response to MVr and TEER. 3. To construct functional pre-operative CMR fingerprints that recapitulate the mechanical state of the heart to develop individualized computational models, which will be altered in silico based on the proposed treatment plan, to predict patients' response to therapy. These results will be validated against post-operative outcome data to test the validity of this approach for predicting treatment response. 4. To explore the relationships among gene products, structural variables, and post-operative clinical outcomes, including reverse remodeling, using tissue obtained at surgery from ventricular myocardium.

Mitral Valve ProlapseLeft Ventricular FibrosisVentricular Arrhythmias

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 60 Years and over
Who can join: All genders

What the study is looking for

✓Patients who meet all eligibility criteria and are randomly assigned in the parent PRIMARY trial.
✓For the ancillary biospecimen study, patients who are randomly assigned to MVr in the parent trial.

Who cannot take part

✗Severe claustrophobia not controlled with sedation.
✗Prior adverse reaction to gadolinium administration.
✗Known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies (for patients...

See the full criteria

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).