Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Recruiting

• Conditions: Mitral Valve Prolapse; Ventricular Tachycardia; Mitral Regurgitation
• Interventions: Procedure: Mitral valve surgery

• Registration Number: NCT06255457
• Lead Sponsor: Karolinska Institutet

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2024-02-04
• Study First Submitted QC: 2024-02-04
• Study First Posted: 2024-02-13
• Study Start: 2024-02-21
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse	Mitral valve surgery	Surgical repair or replacement of the mitral valve due to significant mitral regurgitation according to standard of care.

Primary Outcome Measures

Name	Time	Method
Extracellular volume	6 months	Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR
Ventricular arrhythmias	6 months	Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)

Trial Locations

Locations (1)

Karolinska Univeristy Hospital; 🇸🇪 Stockholm, Sweden