Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery (MVP-A&S)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Prolapse; Cardiac Arrhythmia

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Guido Ascione, MD; Phone Number: 0226437102; Email: ascione.guido@hsr.it
• Study Contact Backup: Name: Pasquale Vergara, MD, PhD; Email: pasqualevergara@hotmail.com

Study Locations

• Italy
  • Milano, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele Scientific Institute
    • Contact: Nicolò Azzola Guicciardi, MD; Email: nico.azzola@gmail.com
    • Principal Investigator: Pasquale Vergara, MD, PhD
    • Principal Investigator: Michele De Bonis, MD
    • Principal Investigator: Guido Ascione, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of MVP and any documented VA.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ospedale San Raffaele
• Investigators: Principal Investigator: Pasquale Vergara, MD, PhD, IRCCS San Raffaele Scientific Institute; Principal Investigator: Michele De Bonis, MD, IRCCS San Raffaele Scientific Institute; Principal Investigator: Guido Ascione, MD, IRCCS San Raffaele Scientific Institute

Publications and helpful links

General Publications

• Vergara P, Scarfò I, Esposito A, Colantoni C, Palmisano A, Altizio S, Falasconi G, Pannone L, Lapenna E, Gulletta S, Alfieri O, Castiglioni A, Maisano F, De Bonis M, Della Bella P, La Canna G. Characterization of the electrophysiological substrate in patients with Barlow's disease. J Cardiovasc Electrophysiol. 2021 Dec;32(12):3179-3186. doi: 10.1111/jce.15270. Epub 2021 Oct 28.
• Guicciardi NA, De Bonis M, Di Resta C, Ascione G, Alfieri O, Maisano F, Vergara P. Genetic background of mitral valve prolapse. Rev Cardiovasc Med. 2022 Mar 12;23(3):96. doi: 10.31083/j.rcm2303096. Review.
• Vergara P, Altizio S, Falasconi G, Pannone L, Gulletta S, Della Bella P. Electrophysiological Substrate in Patients with Barlow's Disease. Arrhythm Electrophysiol Rev. 2021 Apr;10(1):33-37. doi: 10.15420/aer.2020.29. Review.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Anticipated): February 10, 2025
• Study Completion (Anticipated): February 10, 2026

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: October 2, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Mitral valve surgery; Sudden Cardiac Death; Premature Ventricular Contraction
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Prolapse; Arrhythmias, Cardiac; Mitral Valve Prolapse
• Other Study ID Numbers: MITRALE 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No