Exploring the relationship between mitral valve prolapse and arrhythmias
Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery
This study is testing how mitral valve prolapse affects heart rhythm problems and whether surgery can help improve those issues in people who have both conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 1 site (Milano) |
| Trial ID | NCT05562804 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the connection between mitral valve prolapse (MVP) and malignant ventricular arrhythmias, as well as the impact of mitral valve surgery on arrhythmic patterns. It will enroll 200 patients diagnosed with MVP and any documented ventricular arrhythmias, utilizing 12-lead ECG and Holter monitoring to assess arrhythmic burden. The study will also collect demographic, clinical, and echocardiographic data to better understand the risk factors associated with arrhythmias in this population. Follow-up monitoring will occur at 3, 9, and 12 months post-surgery to evaluate changes in arrhythmic patterns.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of mitral valve prolapse who have undergone electrophysiological evaluation or cardiac surgery.
Not a fit: Patients who are unwilling to participate or do not have a clinical evaluation of their arrhythmic profile may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of patients with mitral valve prolapse and associated arrhythmias.
How similar studies have performed: While this study addresses a significant gap in understanding the relationship between MVP and arrhythmias, similar observational studies have shown promise in elucidating arrhythmic risks in cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult 18 years of age or older, at the time of inclusion; 2. Hospitalized or presented in outpatient visit; 3. And presented with: • Diagnosis of MVP 4. Who underwent electrophysiological evaluation or cardiac surgery for mitral valve disease. Exclusion Criteria: 1. Patients not willing to participate to the study 2. Patients without clinical evaluation of the arrhythmic profile.
Where this trial is running
Milano
- IRCCS San Raffaele Scientific Institute — Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Pasquale Vergara, MD, PhD — IRCCS San Raffaele Scientific Institute
- Study coordinator: Guido Ascione, MD
- Email: ascione.guido@hsr.it
- Phone: 0226437102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.