An interventional study of Tricuspid Valve Annuloplasty in Tricuspid Valve Insufficiency, sponsored by Hasselt University. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-24.
Sponsored by Hasselt University · Not applicable, Interventional, and Treatment
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.
219 studies on the registry are indexed under Tricuspid Valve Insufficiency; 106 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 118 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
combination of all-cause mortality or heart failure hospitalisation
Time frame: at 12 months post-surgery
RV function & geometry
volumes and ejection fraction Assessed by cardiac ultrasound and MRI
Time frame: 3, 6, 12 and 18 months
Quality of Life
Change at follow-up, measured by SF-36 \& Minnesota Living with Heart Failure scale.
Time frame: 6, 12 and 18 months
Duration of Hospital and ICU stay
Time frame: postoperative phase
All-Cause Mortality
Time frame: at 3, 6, 12 and 18 months post-surgery
Hospitalization for Heart Failure
Time frame: at 3, 6, 12 and 18 months post-surgery
progressive TR > 2+ post-surgery
Time frame: 3, 6, 12 and 18 months
cardiovascular mortality
Time frame: at 3, 6, 12 and 18 months post-surgery
Exercise Tolerance
Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)
Time frame: 6, 12 and 18 months
This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Tricuspid Valve Insufficiency→
Hasselt University