Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery (MVP-A&S)

  • STATUS
    Recruiting
  • End date
    Feb 10, 2026
  • participants needed
    200
  • sponsor
    Ospedale San Raffaele
Updated on 25 October 2022
cardiac death

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.

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.

Details
Condition Mitral Valve Prolapse, Cardiac Arrhythmia
Clinical Study IdentifierNCT05562804
SponsorOspedale San Raffaele
Last Modified on25 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult 18 years of age or older, at the time of inclusion
Hospitalized or presented in outpatient visit
And presented with
• Diagnosis of MVP
Who underwent electrophysiological evaluation or cardiac surgery for mitral valve disease

Exclusion Criteria

Patients not willing to participate to the study
Patients without clinical evaluation of the arrhythmic profile
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