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RecruitingNCT05562804MVP-A&SUpdated Oct 4, 2022

Mitral Valve Prolapse, Arrhythmias and Mitral Valve Surgery

An observational study in Mitral Valve Prolapse and Cardiac Arrhythmia, sponsored by Ospedale San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-04.

Sponsored by Ospedale San Raffaele · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Feb 2021; still recruiting 5 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mitral Valve Prolapse
  • Cardiac Arrhythmia

Keywords

  • Sudden Cardiac Death
  • Premature Ventricular Contraction
  • Mitral valve surgery
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Ospedale San Raffaele is the lead sponsor of 46 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with diagnosis of MVP and any documented VA.

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

Exclusion Criteria:

  1. Patients not willing to participate to the study
  2. Patients without clinical evaluation of the arrhythmic profile.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Presence of significant arrhythmic burden in MVP patients

    Time frame: At enrollment

Secondary outcomes

  1. Disappearance of significant arrhythmic burden after mitral valve surgery

    Time frame: 3, 9, 12 months after mitral valve surgery

07

Study locations

1 of 1 sites recruiting
  • IRCCS San Raffaele Scientific Institute
    Milano, 20132, Italy
    • Nicolò Azzola Guicciardi, MD · Contact · nico.azzola@gmail.com
    • Pasquale Vergara, MD, PhD · Principal investigator
    • Michele De Bonis, MD · Principal investigator
    • Guido Ascione, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34664762 ↗
  • 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. PubMed 35345263 ↗
  • 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. PubMed 33936741 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05562804
Lead sponsor
Ospedale San Raffaele
Responsible party
Michele De Bonis (Clinical Professor, Ospedale San Raffaele) — Principal investigator
First posted
Oct 3, 2022
Start date
Feb 10, 2021
Primary completion
Feb 10, 2025 (estimated)
Completion
Feb 10, 2026 (estimated)
Last update
Oct 4, 2022

Study contacts

Guido Ascione, MD
Contact
ascione.guido@hsr.it
0226437102
Pasquale Vergara, MD, PhD
Contact
pasqualevergara@hotmail.com
Pasquale Vergara, MD, PhD
principal investigator · IRCCS San Raffaele Scientific Institute
Michele De Bonis, MD
principal investigator · IRCCS San Raffaele Scientific Institute
Guido Ascione, MD
principal investigator · IRCCS San Raffaele Scientific Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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