Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery
NCT ID: NCT05562804
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2021-02-10
2026-02-10
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. Patients without clinical evaluation of the arrhythmic profile.
18 Years
ALL
No
Sponsors
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Ospedale San Raffaele
OTHER
Responsible Party
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Michele De Bonis
Clinical Professor
Principal Investigators
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Pasquale Vergara, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Michele De Bonis, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Guido Ascione, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele Scientific Institute
Locations
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IRCCS San Raffaele Scientific Institute
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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MITRALE 2019
Identifier Type: -
Identifier Source: org_study_id
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