Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery (Mitra-VT)

Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation; Ventricular Tachycardia; Mitral Valve Prolapse
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Estimated): 90

Contacts and Locations

Study Locations

• Sweden
  • Stockholm County
    • Stockholm, Stockholm County, Sweden, 171 76
      • Recruiting
      • Karolinska Univeristy Hospital
      • Contact: Bahira Shahim, MD, PhD; Phone Number: +46705347350; Email: bahira.shahim@ki.se
      • Principal Investigator: Bahira Shahim, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with and without arrhythmogenic MVP with primary mitral regurgitation eligible for mitral valve surgery according to current standard of care.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Mitral valve surgery; Mitral valve repair or replacement of mitral regurgitation

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Valve Diseases; Heart Valve Prolapse; Tachycardia; Pathological Conditions, Signs and Symptoms; Mitral Valve Insufficiency; Tachycardia, Ventricular; Mitral Valve Prolapse
• Other Study ID Numbers: VR 2022-01472; SG-23-0142-B (Other Grant/Funding Number: Svenska Sällskapet för Medicinsk Forskning (SSMF)); 987010 (Other Grant/Funding Number: Svenska Läkaresällskapet (SLS)); 20220524 (Other Grant/Funding Number: Hjärtlungfonden (HLF)); 2-116/2023 (Other Grant/Funding Number: karolinska Institutet)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No