Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
Mitral valve prolapse (MVP) affects up to 3% of the general population and a small subset of patients is at risk for ventricular arrhythmias. This subgroup is referred to as AMVP (arrhythmic MVP) and was recently defined using the following criteria: (1) Presence of MVP), (2) Ventricular arrhythmia that is either frequent (≥5% total premature ventricular contraction (PVC) burden on Holter) or complex (non-sustained ventricular tachycardia (nsVT), ventricular tachycardia (VT), or ventricular fibrillation (VF)), and (3) The absence of any other well-defined arrhythmic substrate.
Currently, diagnosis is often based on repeated 24-hour Holter monitoring. However, the ventricular arrhythmia burden varies from day-to-day and long-term rhythm monitoring has shown in other pathologies to increase the diagnostic yield with up to 200% (from 22.5% on 24h to 75.3% on 14 days).
This pilot study aims to study the diagnostic yield of long-term rhythm monitoring in patients with MVP as well as the day-to-day variability of ventricular arrhythmias to facilitate power calculation for a future large-scale prospective registry.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older
Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI
New York Heart association classification ≥3 for cohort 3 and classification 1 or 2 for cohorts 1 and 2
Willing and able to provide signed written informed consent
Disqualifiers
Prior cardiac surgery, including previous mitral valve intervention
Prior endovascular mitral valve repair (MitraClip)
Previous catheter ablation of ventricular arrhythmias
Patients not in sinus rhythm
Trial design
Design model
Single group
Treatments tested in this trial
14-day rhythm monitoring
Diagnostic testEligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: 14 day monitoringExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to arrhythmic mitral valve prolapse detection
The number of days to reach the detection of arrhythmic mitral valve prolapse, defined as a PVC burden ≥ 5%, nsVT, VT or VF
Time frame
14 days2
Number of days with high PVC-burden ≥5%
Number of days with a PVC-burden ≥5%
Time frame
14 days3
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
Number of days with ≥ 1 nsVT, VT or VF episode
Time frame
14 days4
Day-to-day variation in percentage PVC burden
Day-to-day variation of the absolute number of PVC burden in percentage
Time frame
14 daysSecondary outcomes
1
Association between percentage PVC burden and percentage of late gadolinium enhancement on cardiac MRI
Correlation analysis of two continuous variables. The PVC burden will be calculated as the number of PVCs divided by the total number of heartbeats during the 14 days rhythm monitoring. Percentage of late gadolinium enhancement will be calculated as the ratio of the mass of myocardial tissue with late gadolinium enhancement over the total LV mass on cardiac MRI.
Time frame
14 days2
Association between mean number of nsVT episodes per 24hours and percentage of late gadolinium enhancement on cardiac MRI
Correlation analysis of two continuous variables. The mean number of nsVT episodes will be calculated as the average of nsVT episoden per day during the 14 days rhythm monitoring. Percentage of late gadolinium enhancement will be calculated as the ratio of the mass of myocardial tissue with late gadolinium enhancement over the total LV mass on cardiac MRI
Time frame
14 days3
Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography
Correlation analysis of two continuous variables. The PVC burden will be calculated as the number of PVCs divided by the total number of heartbeats during the 14 days rhythm monitoring. Global longitudinal strain will be measured using conventional echocardiography on the 2-chamber, 3-chamber, and 4-chamber apical view.
Time frame
14 days4
Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography
Correlation analysis of two continuous variables. Correlation analysis of two continuous variables. The mean number of nsVT episodes will be calculated as the average of nsVT episoden per day during the 14 days rhythm monitoring. Global longitudinal strain will be measured using conventional echocardiography on the 2-chamber, 3-chamber, and 4-chamber apical view.
Time frame
14 daysSponsors and contacts
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Source ClinicalTrials.gov