Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedOctober 24, 2014
October 1, 2014
6.3 years
October 18, 2011
October 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
combination of all-cause mortality or heart failure hospitalisation
at 12 months post-surgery
Secondary Outcomes (8)
RV function & geometry
3, 6, 12 and 18 months
Quality of Life
6, 12 and 18 months
Duration of Hospital and ICU stay
postoperative phase
All-Cause Mortality
at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure
at 3, 6, 12 and 18 months post-surgery
- +3 more secondary outcomes
Study Arms (2)
Tricuspid Valve Annuloplasty
EXPERIMENTALPatients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty.
Conservative arm
NO INTERVENTIONPatients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to mitral valve surgery without concomitant tricuspid valve annuloplasty.
Interventions
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
Eligibility Criteria
You may qualify if:
- Scheduled for mitral valve surgery
- Tricuspid Annular diameter \> 40mm or \>21mm/m²
You may not qualify if:
- Tricuspid Regurgitation more than 2+
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ziekenhuis Oost-Limburg (General Hospital Genk)
Genk, 3600, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Cardiovascular Physiology
Study Record Dates
First Submitted
October 18, 2011
First Posted
April 19, 2012
Study Start
August 1, 2011
Primary Completion
December 1, 2017
Last Updated
October 24, 2014
Record last verified: 2014-10