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Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

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ClinicalTrials.gov Identifier: NCT01580436
Recruitment Status : Unknown
Verified October 2014 by Wilfried Mullens, MD PhD, Hasselt University.
Recruitment status was:  Recruiting
First Posted : April 19, 2012
Last Update Posted : October 24, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Tricuspid Valve Insufficiency Procedure: Tricuspid Valve Annuloplasty

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
Study Start Date : August 2011
Estimated Primary Completion Date : December 2017
Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. combination of all-cause mortality or heart failure hospitalisation [ Time Frame: at 12 months post-surgery ]

Secondary Outcome Measures :
  1. RV function & geometry [ Time Frame: 3, 6, 12 and 18 months ]
    volumes and ejection fraction Assessed by cardiac ultrasound and MRI

  2. Quality of Life [ Time Frame: 6, 12 and 18 months ]
    Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.

  3. Duration of Hospital and ICU stay [ Time Frame: postoperative phase ]
  4. All-Cause Mortality [ Time Frame: at 3, 6, 12 and 18 months post-surgery ]
  5. Hospitalization for Heart Failure [ Time Frame: at 3, 6, 12 and 18 months post-surgery ]
  6. progressive TR > 2+ post-surgery [ Time Frame: 3, 6, 12 and 18 months ]
  7. cardiovascular mortality [ Time Frame: at 3, 6, 12 and 18 months post-surgery ]
  8. 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)


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wilfried Mullens, MD PhD, Professor Cardiovascular Physiology, Hasselt University
ClinicalTrials.gov Identifier: NCT01580436     History of Changes
Other Study ID Numbers: TVP Study
First Posted: April 19, 2012    Key Record Dates
Last Update Posted: October 24, 2014
Last Verified: October 2014

Keywords provided by Wilfried Mullens, MD PhD, Hasselt University:
Tricuspid Valve Insufficiency
Cardiac Valve Annuloplasty
Outcome Assessment (Health Care)

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