Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
This study is currently recruiting participants.
Verified April 2012 by Hasselt University
Sponsor:
Hasselt University
Information provided by (Responsible Party):
Wilfried Mullens, MD PhD, Hasselt University
ClinicalTrials.gov Identifier:
NCT01580436
First received: October 18, 2011
Last updated: April 18, 2012
Last verified: April 2012
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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
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: | April 18, 2012 |
| 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 Heart Valve Diseases Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013