Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

Recruiting Phase 3 Interventional Study
Mitral Valve Prolapse Ventricular Arrhythmias and Cardiac Arrest
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Oslo University Hospital · Other
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About This Trial

FLECAPRO is a randomized controlled crossover trial assessing the effect and safety of adding flecainide to standard beta-blocker therapy to reduce the burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. The primary endpoint of will be assessed using an implantable loop recorder with blinded endpoint adjudication.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Participants must be 18 years of age or older at the time of signing the informed consent. * Participants must have mitral valve prolapse evident by echocardiography or cardiac magnetic resonance imaging, defined as more than or equal to 2 mm atrial displacement of any part of…
Contacts

Eivind W Aabel, MD PhD

41243148

eivind.westrum.aabel@gmail.com

CONTACT