Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mitral valve surgery.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation, Mitral Valve Prolapse, Ventricular Tachycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Mechanisms and Outcomes in Patients With Arrhythmic Mitral Valve Prolapse Undergoing Mitral Valve Surgery
Overview
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
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.
Interventions
- Procedure Mitral valve surgery
Mitral valve repair or replacement of mitral regurgitation
Primary outcome measures
- Ventricular arrhythmias [Time frame: 6 months]
- Extracellular volume [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 1 center
- Karolinska Univeristy Hospital — Stockholm
Identifiers
NCT: NCT06255457 · VR 2022-01472 · SG-23-0142-B · 987010 · 20220524 · 2-116/2023