Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

NCT06255457 | Recruiting

• 5 other identifiers: VR 2022-01472SG-23-0142-B987010202205242-116/2023
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Mitral Regurgitation; Mitral Valve Prolapse; Ventricular Tachycardia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Mitral valve surgery PROCEDURE

Mitral valve repair or replacement of mitral regurgitation

Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator

Study Sites (1)

Karolinska Univeristy Hospital

Stockholm, Stockholm County, 171 76, Sweden

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Prolapse; Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Valve Prolapse; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: February 21, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)