Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring

Ventricular Arrythmia Clinical Trial

— ALARM-PILOT  

Official title:

Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378996
• Other study ID #: S68535
• Status: Recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Bert Vandenberk, MD PhD
• Phone: +3216338686
• Email: vandenberkbert[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 years or older

• Mitral valve prolapse diagnosed on previous echocardiography or cardiac MRI

• New York Heart association classification =3

• Willing and able to provide signed written informed consent

• No contra-indication for long-term monitoring (known allergy to adhesives)

Exclusion Criteria:

• 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

• Patients on anti-arrhythmic drugs but betablockers

• Known alternative arrhythmic substrate, for example previous myocardial infarction

• Known allergy to adhesives

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse
• Ventricular Arrythmia

Intervention

Diagnostic Test:
• 14-day rhythm monitoring
Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days
Primary	Number of days with high PVC-burden =5%	Number of days with a PVC-burden =5%	14 days
Primary	Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)	Number of days with = 1 nsVT, VT or VF episode	14 days
Primary	Day-to-day variation in percentage PVC burden	Day-to-day variation of the absolute number of PVC burden in percentage	14 days
Secondary	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.	14 days
Secondary	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	14 days
Secondary	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.	14 days
Secondary	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.	14 days