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TerminatedNCT02357862Updated May 8, 2018

Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

An observational study in Tricuspid (Valve); Deformity, sponsored by Universitaire Ziekenhuizen KU Leuven. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-08.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
22
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.

Read the detailed description

The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.

02

Conditions studied

  • Tricuspid (Valve); Deformity

Keywords

  • Cardiovascular Diseases
  • Heart Valve Diseases
  • Mitral Valve Annuloplasty
  • Tricuspid Valve Insufficiency
03

In context

Congenital Abnormalities

980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.

This study's enrollment of 22 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.

Browse Congenital Abnormalities studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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 undergoing minimally invasive, isolated mitral valve annuloplasty in the University Hospitals Leuven

Inclusion criteria

  • all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty

Exclusion criteria

Exclusion Criteria:

  • concomitant tricuspid valve surgery
  • atrial fibrillation at the moment of surgery
  • poor echocardiographic windows
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • Mitral Valve Annuloplasty

    All eligible patients

    Procedure: Mitral Valve Annuloplasty

Interventions

  • ProcedureMitral Valve Annuloplasty

    Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion

06

What researchers measure

Primary outcomes

  1. Postoperative geometric changes in tricuspid valve annulus (TA)

    Measurement of changes in 3D descriptors of the TA (e.g. changes from baseline in the TA area of the best-fit plane in cm\^2, and changes from baseline in the height of each TA point to the TA best-fit plane in mm)

    Time frame: day 0

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02357862
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Feb 6, 2015
Start date
Jan 2015
Primary completion
Feb 2016
Completion
Feb 2016
Last update
May 8, 2018

Study contacts

Werner Budts, M.D., PhD
principal investigator · KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology

Oversight

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

Not currently enrolling

This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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