Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

ConditionsMitral Regurgitation Mitral Valve Prolapse Ventricular Tachycardia

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorKarolinska Institutet

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with and without arrhythmogenic MVP with primary mitral regurgitation eligible for mitral valve surgery according to current standard of care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Mitral valve surgery
Procedure/Surgery
Mitral valve repair or replacement of mitral regurgitation

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: Arrhythmogenic mitral valve prolapse versus non-arrhythmogenic mitral valve prolapse1 intervention

Trial outcomes

Primary outcomes

Ventricular arrhythmias

Change in ventricular arrhythmic burden (composite of non-sustained or sustained ventricular tachycardias, ventricular fibrillation or premature ventricular complexes)

Time frame

6 months

Extracellular volume

Change in indexed extracellular volume as surrogate marker for diffuse reversible fibrosis measured by CMR

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Karolinska University Hospital

Collaborator

Source ClinicalTrials.gov

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