Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-21

Study Completion Date

2026-03-01

Brief Summary

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Study objectives:

* To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery
* To characterize the molecular landscape of arrhytmogenic MVP

Study design:

-Prospective explorative observational study

Study population:

-90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery

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Detailed Description

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Prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and CMR imaging biomarkers will be examined in patients with arrhythmogenic MVP compared to those without arrhythmogenic MVP (controls). Molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic MVP will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep RNA single cell sequencing. Using CMR in 90 patients with MVP before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. To assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with E-patch at baseline and at 6 months after mitral valve surgery. During surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.

Conditions

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Mitral Regurgitation Mitral Valve Prolapse Ventricular Tachycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse

Surgical repair or replacement of the mitral valve due to significant mitral regurgitation according to standard of care.

Mitral valve surgery

Intervention Type PROCEDURE

Mitral valve repair or replacement of mitral regurgitation

Interventions

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Mitral valve surgery

Mitral valve repair or replacement of mitral regurgitation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 18 and over
* Patients with and without (controls) arrhythmogenic MVP in need of mitral valve surgery for primary mitral regurgitation according to current standard of care

Exclusion Criteria

* Secondary mitral regurgitation
* Primary mitral regurgitation not due to degenerative disease (including rheumatic disease)
* Co-existing moderate or severe aortic valve disease
* Congenital heart disease
* Inherited or acquired cardiomyopathy
* Non-incidental or symptomatic coronary artery disease
* Uncontrolled atrial fibrillation (resting heart rate \> 100/min)
* Pregnancy
* Unable to undergo CMR

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No