Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05562804

Acronym

MVP-A&S

Enrollment

200

Registered

2022-10-03

Start date

2021-02-10

Completion date

2026-02-10

Last updated

2022-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia, Mitral Valve Prolapse

Keywords

Sudden Cardiac Death, Premature Ventricular Contraction, Mitral valve surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Presence of significant arrhythmic burden in MVP patients	At enrollment

Secondary

Measure	Time frame
Disappearance of significant arrhythmic burden after mitral valve surgery	3, 9, 12 months after mitral valve surgery

Countries

Italy

Contacts

Primary ContactGuido Ascione, MD

ascione.guido@hsr.it0226437102

Backup ContactPasquale Vergara, MD, PhD

pasqualevergara@hotmail.com

Outcome results