Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378996
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-04-10
Brief Title:
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALARM-PILOT
Brief Summary:
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 225 on 24h to 753 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
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 225 on 24h to 753 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None