Mitral Valve ProlapseALARM-PILOTNCT06378996
Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm Monitoring
A study testing 14-day rhythm monitoring in people with Mitral Valve Prolapse and Ventricular Arrythmia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse, Ventricular Arrythmia
- What is being tested?
- 14-day rhythm monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2024to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- No contra-indication for long-term monitoring (known allergy to adhesives)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
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.
- Conditions
- Mitral Valve Prolapse, Ventricular Arrythmia
- Being tested
- 14-day rhythm monitoring
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-day rhythm monitoringDiagnostic test
Eligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor.
| Study group | Role | What they receive |
|---|---|---|
| 14 day monitoring | Experimental | Not described Receives: Diagnostic Test: 14-day rhythm monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Number of days with high PVC-burden ≥5%
Number of days with a PVC-burden ≥5%
Measured: 14 days
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
Number of days with ≥ 1 nsVT, VT or VF episode
Measured: 14 days
Day-to-day variation in percentage PVC burden
Day-to-day variation of the absolute number of PVC burden in percentage
Measured: 14 days
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 May 2024
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single arm, interventional cohort study including 3 different patient cohorts: * Cohort 1: Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation * Cohort 2: Patients with AMVP and mild to moderate mitral valve regurgitation * Cohort 3: Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06378996
- Sponsor's protocol ID
- S68535
- Acronym
- ALARM-PILOT
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2024
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arrhythmic Mitral Valve Prolapse Detection Using Long-term Ambulatory Rhythm - A Pilot Study
- ClinicalTrials.gov ID
- NCT06378996
- Acronym / sponsor ID
- ALARM-PILOT / S68535
- Conditions
- Mitral Valve Prolapse, Ventricular Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm, interventional cohort study including 3 different patient cohorts: * Cohort 1: Patients with MVP (not previously known with AMVP) and mild to moderate mitral valve regurgitation * Cohort 2: Patients with AMVP and mild to moderate mitral valve regurgitation * Cohort 3: Patients with MVP and severe mitral valve regurgitation scheduled for surgical intervention
| Arm | Type | Receives |
|---|---|---|
| 14 day monitoring | Experimental | Diagnostic Test: 14-day rhythm monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- No contra-indication for long-term monitoring (known allergy to adhesives)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14-day rhythm monitoringEligible patients will be monitored during 14 days using the Byteflies patch ambulatory rhythm monitor. | Diagnostic test | 14 day monitoring |
Primary outcome
Time to arrhythmic mitral valve prolapse detection
Time frame: 14 days
The number of days to reach the detection of arrhythmic mitral valve prolapse, defined as a PVC burden ≥ 5%, nsVT, VT or VF
Number of days with high PVC-burden ≥5%
Time frame: 14 days
Number of days with a PVC-burden ≥5%
Number of days with complex ventricular arrhythmia (nsVT, VT, or VF)
Time frame: 14 days
Number of days with ≥ 1 nsVT, VT or VF episode
Day-to-day variation in percentage PVC burden
Time frame: 14 days
Day-to-day variation of the absolute number of PVC burden in percentage
4 secondary outcomes
Association between percentage PVC burden and percentage of late gadolinium enhancement 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
Time frame: 14 days
Association between percentage PVC burden and global longitudinal strain on transthoracic echocardiography
Time frame: 14 days
Association between mean number of nsVT episodes per 24hours and global longitudinal strain on transthoracic echocardiography
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 14-day rhythm monitoring in people with Mitral Valve Prolapse and Ventricular Arrythmia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to arrhythmic mitral valve prolapse detection (time frame: 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.