Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

May 2, 2018 updated by: Universitaire Ziekenhuizen KU Leuven

Impact of Mitral Valve Annuloplasty on the Tricuspid Valve Complex

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

22

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mitral Valve Annuloplasty
All eligible patients
Procedure: Mitral Valve Annuloplasty
Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative geometric changes in tricuspid valve annulus (TA)
Time Frame: day 0
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)
day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Werner Budts, M.D., PhD, KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (ESTIMATE)

February 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVR_TV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tricuspid (Valve); Deformity

Clinical Trials on Mitral Valve Annuloplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe