NCT06255457 Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
| NCT ID | NCT06255457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 90 participants |
| Start Date | 2024-02-21 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 90 participants in total. It began in 2024-02-21 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Frequently Asked Questions
Who can join the NCT06255457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06255457 currently recruiting?
Yes, NCT06255457 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karolinska Institutet to inquire about joining.
Where is the NCT06255457 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06255457 clinical trial?
NCT06255457 is sponsored by Karolinska Institutet. The trial plans to enroll 90 participants.