Actively Recruiting
Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery
Led by Karolinska Institutet · Updated on 2025-09-11
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand how mitral valve surgery affects ventricular arrhythmias and fibrosis markers in patients with arrhythmogenic mitral valve prolapse (MVP) who have mitral regurgitation. The study will also explore the molecular characteristics of arrhythmogenic MVP. It involves both patients with arrhythmogenic MVP and control patients without arrhythmogenic MVP, all scheduled for mitral valve surgery. Participants will undergo mitral valve surgery, which includes either repair or replacement due to mitral regurgitation, following the current standard of care. The study will use cardiac magnetic resonance imaging (CMR) and continuous seven-day arrhythmic monitoring before surgery and again six months afterward to assess changes. During surgery, tissue samples from the mitral valve and endocardial biopsies will be collected for detailed molecular analysis. Participants will be closely monitored through imaging and arrhythmia tracking before and six months after surgery. Researchers will measure ventricular arrhythmias and extracellular volume as primary outcomes to evaluate changes after surgery. The study involves 90 patients and includes molecular phenotyping to better understand the disease mechanisms. The total study time for each participant is at least six months following their surgery.
CONDITIONS
Brief Title
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 and over
- Patients with and without arrhythmogenic mitral valve prolapse needing mitral valve surgery for primary mitral regurgitation according to current standard of care
You will not qualify if you...
- 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 cardiac magnetic resonance imaging (CMR)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo mitral valve surgery including repair or replacement as per standard care. Tissue samples are collected during surgery for molecular analysis.
1 surgical visit (in-person)
Duration - 6 months
Participants are monitored with cardiac magnetic resonance imaging (CMR) and continuous seven-day E-patch monitoring to assess ventricular arrhythmias and cardiac fibrosis at baseline and 6 months after surgery.
2 visits (in-person) including baseline and 6-month follow-up; continuous 7-day monitoring at each visit
Trial Site Locations
Total: 1 location
1
Karolinska Univeristy Hospital
Stockholm, Stockholm County, Sweden, 171 76
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here