Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

October 23, 2014 updated by: Wilfried Mullens, MD PhD, Hasselt University

Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

De novo or progressive tricuspid regurgitation (TR) is not uncommonly observed following mitral valve surgery and associated with worse outcome. Hence, concomitant tricuspid valve annuloplasty (TVP) has been recommended for patients undergoing mitral valve surgery when tricuspid annular dilatation is present even in absence of significant TR. However, whether such a strategy of "prophylactic TVP" results in improved outcomes has not been shown to date by a prospective randomized study. The investigators goal is therefore to initiate such a study and evaluate the effect of concomitant TVP on mid- and long-term outcome in patients scheduled for mitral valve surgery and tricuspid annular dilatation but <2+ TR.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium, 3600
        • Recruiting
        • Ziekenhuis Oost-Limburg (General Hospital Genk)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Wilfried Mullens, MD, PhD
        • Sub-Investigator:
          • Robert Dion, MD, PhD
        • Sub-Investigator:
          • Pieter Vandervoort, MD

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

Description

Inclusion Criteria:

  • Scheduled for mitral valve surgery
  • Tricuspid Annular diameter > 40mm or >21mm/m²

Exclusion Criteria:

  • Tricuspid Regurgitation more than 2+
  • Unable to provide informed consent

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tricuspid Valve Annuloplasty
Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty.
Procedure: Tricuspid Valve Annuloplasty
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
No Intervention: Conservative arm
Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to mitral valve surgery without concomitant tricuspid valve annuloplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combination of all-cause mortality or heart failure hospitalisation
Time Frame: at 12 months post-surgery
at 12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RV function & geometry
Time Frame: 3, 6, 12 and 18 months
volumes and ejection fraction Assessed by cardiac ultrasound and MRI
3, 6, 12 and 18 months
Quality of Life
Time Frame: 6, 12 and 18 months
Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.
6, 12 and 18 months
Duration of Hospital and ICU stay
Time Frame: postoperative phase
postoperative phase
All-Cause Mortality
Time Frame: at 3, 6, 12 and 18 months post-surgery
at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure
Time Frame: at 3, 6, 12 and 18 months post-surgery
at 3, 6, 12 and 18 months post-surgery
progressive TR > 2+ post-surgery
Time Frame: 3, 6, 12 and 18 months
3, 6, 12 and 18 months
cardiovascular mortality
Time Frame: at 3, 6, 12 and 18 months post-surgery
at 3, 6, 12 and 18 months post-surgery
Exercise Tolerance
Time Frame: 6, 12 and 18 months
Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)
6, 12 and 18 months

Collaborators and Investigators

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

Sponsor

Hasselt University

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

August 1, 2011

Primary Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 18, 2011

First Submitted That Met QC Criteria

April 18, 2012

First Posted (Estimate)

April 19, 2012

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TVP Study

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 Insufficiency

Clinical Trials on Tricuspid Valve Annuloplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe