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Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Hasselt University
Sponsor:
Information provided by (Responsible Party):
Wilfried Mullens, MD PhD, Hasselt University
ClinicalTrials.gov Identifier:
NCT01580436
First received: October 18, 2011
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Tricuspid Valve Insufficiency
Procedure: Tricuspid Valve Annuloplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Resource links provided by NLM:


Further study details as provided by Hasselt University:

Primary Outcome Measures:
  • combination of all-cause mortality or heart failure hospitalisation [ Time Frame: at 12 months post-surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • RV function & geometry [ Time Frame: 3, 6, 12 and 18 months ] [ Designated as safety issue: No ]
    volumes and ejection fraction Assessed by cardiac ultrasound and MRI

  • Quality of Life [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.

  • Duration of Hospital and ICU stay [ Time Frame: postoperative phase ] [ Designated as safety issue: No ]
  • All-Cause Mortality [ Time Frame: at 3, 6, 12 and 18 months post-surgery ] [ Designated as safety issue: Yes ]
  • Hospitalization for Heart Failure [ Time Frame: at 3, 6, 12 and 18 months post-surgery ] [ Designated as safety issue: Yes ]
  • progressive TR > 2+ post-surgery [ Time Frame: 3, 6, 12 and 18 months ] [ Designated as safety issue: No ]
  • cardiovascular mortality [ Time Frame: at 3, 6, 12 and 18 months post-surgery ] [ Designated as safety issue: Yes ]
  • Exercise Tolerance [ Time Frame: 6, 12 and 18 months ] [ Designated as safety issue: No ]
    Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)


Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01580436

Contacts
Contact: David Verhaert, MD +32 089 32 70 91 david.verhaert@zol.be
Contact: Chris Beerts +32 089 32 71 91 chris.beerts@zol.be

Locations
Belgium
Ziekenhuis Oost-Limburg (General Hospital Genk) Recruiting
Genk, Belgium, 3600
Contact: David Verhaert, MD    +32 089 32 70 91    david.verhaert@zol.be   
Contact: Chris Beerts    +32 089 32 71 91    chris.beerts@zol.be   
Sub-Investigator: Wilfried Mullens, MD, PhD         
Sub-Investigator: Robert Dion, MD, PhD         
Sub-Investigator: Pieter Vandervoort, MD         
Sponsors and Collaborators
Hasselt University
  More Information

No publications provided

Responsible Party: Wilfried Mullens, MD PhD, Professor Cardiovascular Physiology, Hasselt University
ClinicalTrials.gov Identifier: NCT01580436     History of Changes
Other Study ID Numbers: TVP Study
Study First Received: October 18, 2011
Last Updated: October 23, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Hasselt University:
Tricuspid Valve Insufficiency
Cardiac Valve Annuloplasty
Outcome Assessment (Health Care)

Additional relevant MeSH terms:
Tricuspid Valve Insufficiency
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on November 25, 2014