Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06255457
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-02-04
Brief Title:
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mitra-VT
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2-1162023 | OTHER_GRANT | karolinska Institutet | None |
| SG-23-0142-B | OTHER_GRANT | None | None |
| 987010 | OTHER_GRANT | None | None |
| 20220524 | OTHER_GRANT | None | None |