Mitral Valve Prolapse Arrhythmic Risk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOslo University Hospital
About this trial
Mitral valve prolapse (MVP) is common with a 2-3 % prevalence in the general association and generally associated with a favorable prognosis. However, a subgroup of MVP patients, known as arrhythmic mitral valve prolapse (AMVP) has an increased burden of severe ventricular arrhythmias and risk of sudden cardiac death. Identifying high risk patients who may benefit of potential implantable cardioverter-defibrillator (ICD) implantation is therefore critically important. Risk stratification in AMVP is still challenging, and the ability to estimate arrhythmic risk at the individual level is limited.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
MVP according to the ESC definition AND
A total PVC burden ≥ 0,5 % per day OR
Documentation of NSVT on any modality OR
More severe ventricular arrhythmias (sustained ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest) that occurred >1 month after the beginning of follow up.
Disqualifiers
VT/VF as the initial presentation without prior cardiac evaluation (ECG, echo, Holter)
History of myocardial infarction
Obstructive coronary diseases - ≥50 % stenosis that was not treated
History of coronary artery bypass surgery
Trial population
Mitral Valve Prolapse with Ventricular Arrhythmias
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Risk prediction model
Other interventionA multivariable risk prediction model will be developed and validated to estimate the individual risk of severe ventricular arrhythmias in patients with mitral valve prolapse. The model will be based on clinical, electrocardiographic, arrhythmic, echocardiographic and CMR variables. The risk prediction model is evaluated as part of this observational study and does not constitute a study-specific therapeutic or diagnostic intervention.
Treatment groups
500 Participants
are divided into 1 treatment groupGroup A: Patients with Mitral Valve Prolapse and Ventricular Arrhythmias1 intervention
Trial outcomes
Primary outcomes
1
Occurence and Number of Severe Ventricular Arrhythmias in participants
Occurence and number of severe ventricular arrhythmias, defined as ventricullar fibrillation, sustained ventricular tachycardia, aborted cardiac arrest or appropriate implantable cardioverter-defibrillator (ICD) therapy, occuring more than 1 month after baseline.
Time frame
From >6 months after baseline until the end of available follow-up, minimum follow-up 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov