An interventional study of 14-day rhythm monitoring in Mitral Valve Prolapse and Ventricular Arrythmia, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic
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.
41 studies on the registry are indexed under Mitral Valve Prolapse; 13 are open to participants now.
This study's enrollment of 60 is above the median of 40 across 18 interventional studies indexed under Mitral Valve Prolapse.
Browse Mitral Valve Prolapse studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Diagnostic Test: 14-day rhythm monitoring
Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.
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 days
Number of days with high PVC-burden ≥5%
Number of days with a PVC-burden ≥5%
Time frame: 14 days
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
Number of days with ≥ 1 nsVT, VT or VF episode
Time frame: 14 days
Day-to-day variation in percentage PVC burden
Day-to-day variation of the absolute number of PVC burden in percentage
Time frame: 14 days
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 days
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 days
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 days
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 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven