NCT05562804

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2026

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

September 28, 2022

Last Update Submit

October 2, 2022

Conditions

Mitral Valve ProlapseCardiac Arrhythmia

Keywords

Sudden Cardiac DeathPremature Ventricular ContractionMitral valve surgery

Outcome Measures

Primary Outcomes (1)

  • Presence of significant arrhythmic burden in MVP patients

    At enrollment

Secondary Outcomes (1)

  • Disappearance of significant arrhythmic burden after mitral valve surgery

    3, 9, 12 months after mitral valve surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of MVP and any documented VA.

You may qualify if:

  • Hospitalized or presented in outpatient visit;
  • And presented with:
  • Diagnosis of MVP
  • Who underwent electrophysiological evaluation or cardiac surgery for mitral valve disease.

You may not qualify if:

  • Patients not willing to participate to the study
  • Patients without clinical evaluation of the arrhythmic profile.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, 20132, Italy

RECRUITING

Related Publications (3)

  • 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.

    PMID: 34664762BACKGROUND

  • 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.

    PMID: 35345263BACKGROUND

  • 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.

    PMID: 33936741BACKGROUND

MeSH Terms

Conditions

Mitral Valve ProlapseArrhythmias, CardiacDeath, Sudden, CardiacVentricular Premature Complexes

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart ArrestDeath, SuddenDeathCardiac Complexes, PrematureCardiac Conduction System Disease

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Ascione, MD

CONTACT

0226437102ascione.guido@hsr.it

Pasquale Vergara, MD, PhD

CONTACT

pasqualevergara@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 28, 2022

First Posted

October 3, 2022

Study Start

February 10, 2021

Primary Completion

February 10, 2025

Study Completion

February 10, 2026

Last Updated

October 4, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)