Clinical trial NCT05562804: Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery
Official title: Electrophysiological Substrate in Patients With Barlow's Disease: Clinical Predictors of Arrhythmic Events and Impact of Mitral Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Prolapse
Cardiac Arrhythmia
Keywords: Sudden Cardiac Death
Premature Ventricular Contraction
Mitral valve surgery
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosis of MVP and any documented VA.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Presence of significant arrhythmic burden in MVP patients
timeFrame: At enrollment
Secondary outcomes:
measure: Disappearance of significant arrhythmic burden after mitral valve surgery
timeFrame: 3, 9, 12 months after mitral valve surgery
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Pasquale Vergara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Scientific Institute
name: Michele De Bonis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Raffaele Scientific Institute
name: Guido Ascione, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.