Impact of mitral valve surgery on ventricular arrhythmias
Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery
This study is testing how mitral valve surgery helps people with mitral valve prolapse and arrhythmias by looking at their heart health before and after the operation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Stockholm County) |
| Trial ID | NCT06255457 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how mitral valve surgery for mitral regurgitation affects ventricular arrhythmias and related biomarkers in patients with arrhythmogenic mitral valve prolapse (MVP). It will involve 90 patients, including those with and without arrhythmogenic MVP, who will undergo cardiac magnetic resonance imaging and continuous arrhythmic monitoring before and six months after surgery. The study will also analyze molecular characteristics of heart tissue to better understand the underlying mechanisms of arrhythmias in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with arrhythmogenic MVP or those requiring mitral valve surgery for primary mitral regurgitation.
Not a fit: Patients with secondary mitral regurgitation, congenital heart disease, or uncontrolled atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and outcomes for patients undergoing mitral valve surgery who are at risk for ventricular arrhythmias.
How similar studies have performed: While similar studies have explored the relationship between mitral valve surgery and arrhythmias, this specific approach focusing on molecular phenotyping and arrhythmic burden is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Stockholm, Stockholm County
- Karolinska Univeristy Hospital — Stockholm, Stockholm County, Sweden (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.