Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

Recruiting

• Conditions: Mitral Valve Prolapse; Cardiac Arrhythmia

• Registration Number: NCT05562804
• Lead Sponsor: Ospedale San Raffaele

Brief Summary

Mitral valve prolapse (MVP) is associated with malignant ventricular arrhythmias (VA) and sudden cardiac death. A proper electrophysiological and echocardiographic characterization of this population is missing. Moreover, the effects of mitral valve repair on the arrhythmic burden are still matter of debate.

The investigators sought to explore the role of the arrhythmic substrate in the risk stratification of patients with MVP and to assess whether mitral surgery is followed by a significant modification of the baseline arrhythmic pattern.

Detailed Description

This is a prospective observational study, enrolling 200 patients with MVP and any documented VA.

Diagnosis of VA obtained by 12 leads ECG and Holter recordings will be reported, as well as preprocedural premature ventricular contractions (PVC) burden assessed by 24-hour Holter monitoring; demographic and clinical data will be collected, including symptoms, documentation of VA and atrial fibrillation (AF). Echocardiography data will be analyzed, focusing on mitral regurgitation grading and mitral valve morphology analysis, assessment of leaflet redundancy and prolapse, chordal elongation, annular dilatation, presence of calcifications and mitral annular disjunction characterization.

Patients will undergo ECG Holter monitoring before Cardiac Surgery with the aim to identify any VA and estimate PVC burden. ECG Holter monitoring will be repeated at 3, 9, and 12 months after cardiac surgery. In case of intraoperative biopsy, the result of histopathological examination will be collected. For patients undergoing cardiac imaging, including Cardiac Magnetic Resonance or Computer Tomography, data regarding cardiac volumes, function, markers of fibrosis will be collected. In patients undergoing Programmed electrical stimulation (PES) and Electroanatomical Mapping (EAM), size of bipolar and unipolar endocardial abnormal voltage areas, Late Potentials (LP) area, results of programmed electrical stimulation, will be evaluated.

Study Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-09-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-02
• Study First Posted: 2022-10-03
• Last Update Posted: 2022-10-04
• Primary Completion: 2025-02-10
• Study Completion: 2026-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of significant arrhythmic burden in MVP patients	At enrollment

Secondary Outcome Measures

Name	Time	Method
Disappearance of significant arrhythmic burden after mitral valve surgery	3, 9, 12 months after mitral valve surgery

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milano, Italy