NCT03113552

Brief Summary

Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
27mo left

Started Feb 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2013Jul 2028

Study Start

First participant enrolled

February 4, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2028

Last Updated

May 23, 2023

Status Verified

February 1, 2023

Enrollment Period

15.4 years

First QC Date

April 10, 2017

Last Update Submit

May 22, 2023

Conditions

Mitral Valve ProlapseMitral Plasty

Outcome Measures

Primary Outcomes (1)

  • Survival defines as the time between the date of surgery and the death or date of the last news

    6 months

Eligibility Criteria

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

Study of the long-term survival of patients who have had mitral valve prolapse for mitral valve prolapse in Amiens according to the location of the prolapse

You may qualify if:

  • Patients operated between 1988 and 2011
  • Presence of a valvular prolapse diagnosed by echocardiography
  • Possibility of a complete clinical evaluation at the time of the initial echocardiography

You may not qualify if:

  • Ischemic MI (including papillary muscle rupture)
  • Presence of significant aortic valvulopathy, mitral valvular stenosis or congenital disease
  • History of cardiac surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, Picardie, 80054, France

RECRUITING

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve ProlapseHeart Valve DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Catherine SZYMANSKI, Dr

CONTACT

+33322455885szymanski.catherine@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

February 4, 2013

Primary Completion (Estimated)

July 4, 2028

Study Completion (Estimated)

July 4, 2028

Last Updated

May 23, 2023

Record last verified: 2023-02

Locations

FR(1)