Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

Cardiac Arrhythmia Clinical Trial

— MVP-A&S  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562804
• Other study ID #: MITRALE 2019
• Status: Recruiting
• Start date: February 10, 2021
• Est. completion date: February 10, 2026

Study information

• Verified date: October 2022
• Source: Ospedale San Raffaele
• Contact: Guido Ascione, MD
• Phone: 0226437102
• Email: ascione.guido[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 10, 2026
• Est. primary completion date: February 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia
• Mitral Valve Prolapse
• Prolapse

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele Scientific Institute	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of significant arrhythmic burden in MVP patients		At enrollment
Secondary	Disappearance of significant arrhythmic burden after mitral valve surgery		3, 9, 12 months after mitral valve surgery