Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
Primary Purpose
Tricuspid Valve Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tricuspid annuloplasty
Sponsored by
About this trial
This is an interventional treatment trial for Tricuspid Valve Insufficiency
Eligibility Criteria
Inclusion Criteria:
- patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
Exclusion Criteria:
- presence of pacemaker lead through the tricuspid valve
- acute endocarditis
- minimally invasive approach
- Functional mitral valve insufficiency
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Tricuspid annuloplasty
No Tricuspid annuloplasty
Arm Description
Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery
Control patients
Outcomes
Primary Outcome Measures
Incidence of more than mild tricuspid insufficiency
Secondary Outcome Measures
VO2 max
Physical function capacity measured by VO2 max
Right ventricular function
Right ventricle function at the follow up
Full Information
NCT ID
NCT03604484
First Posted
July 11, 2018
Last Updated
July 19, 2018
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03604484
Brief Title
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
Official Title
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2009 (Actual)
Primary Completion Date
December 31, 2010 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.
Detailed Description
The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.
A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tricuspid annuloplasty
Arm Type
Active Comparator
Arm Description
Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery
Arm Title
No Tricuspid annuloplasty
Arm Type
No Intervention
Arm Description
Control patients
Intervention Type
Procedure
Intervention Name(s)
Tricuspid annuloplasty
Intervention Description
Tricuspid annuloplasty
Primary Outcome Measure Information:
Title
Incidence of more than mild tricuspid insufficiency
Time Frame
5 year
Secondary Outcome Measure Information:
Title
VO2 max
Description
Physical function capacity measured by VO2 max
Time Frame
1 year
Title
Right ventricular function
Description
Right ventricle function at the follow up
Time Frame
5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
Exclusion Criteria:
presence of pacemaker lead through the tricuspid valve
acute endocarditis
minimally invasive approach
Functional mitral valve insufficiency
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
We'll reach out to this number within 24 hrs