NCT01537458

Brief Summary

Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly. The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 13, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

March 19, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

January 27, 2023

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

February 13, 2012

Last Update Submit

January 26, 2023

Conditions

Tricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (2)

  • mortality

    10 year

  • Redo surgery

    10 year

Secondary Outcomes (4)

  • functional capacity assessed by CPET

    10 year

  • Atrial fibrillation

    10 year

  • Hospitalisation

    10 year

  • Functional capacity assessed by NYHA functional class

    10 years

Study Arms (1)

Isolated TI repair

Patients that underwent isolated tricuspid valve repair

Procedure: follow-up of isolated tricuspid valve repair

Interventions

follow-up of isolated tricuspid valve repairPROCEDURE

follow-up of patients that underwent TV repair in the past.

Isolated TI repair

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing isolated tricuspid valve repair

You may qualify if:

  • tricuspid valve insufficiency

You may not qualify if:

  • younger than 18 years
  • associated valvular surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 23, 2012

Study Start

March 19, 2012

Primary Completion

June 30, 2012

Study Completion

March 1, 2013

Last Updated

January 27, 2023

Record last verified: 2012-02

Locations

BE(1)