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

• Sponsor: Ospedale San Raffaele (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05562804
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery
• Actual Study Start Date: Feb 10, 2021
• Anticipated Primary Completion Date: Feb 10, 2025
• Anticipated Study Completion Date: Feb 10, 2026

Outcome Measures

Primary Outcome Measures

1. Presence of significant arrhythmic burden in MVP patients [At enrollment]

Secondary Outcome Measures

1. Disappearance of significant arrhythmic burden after mitral valve surgery [3, 9, 12 months after mitral valve surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS San Raffaele Scientific Institute	Milano		Italy	20132

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• Vergara P, Scarfo 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.

• Responsible Party: Michele De Bonis, Clinical Professor, Ospedale San Raffaele
• ClinicalTrials.gov Identifier: NCT05562804
• Other Study ID Numbers: MITRALE 2019
• First Posted: Oct 3, 2022
• Last Update Posted: Oct 4, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michele De Bonis, Clinical Professor, Ospedale San Raffaele: Sudden Cardiac Death; Premature Ventricular Contraction; Mitral valve surgery
• Additional relevant MeSH terms: Arrhythmias, Cardiac; Mitral Valve Prolapse; Prolapse

Study Results

No Results Posted as of Oct 4, 2022