Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Tricuspid Valve Insufficiency Clinical Trial

Official title:

Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604484
• Other study ID #: UCLSaint Luc
• Status: Completed
• Phase: N/A
• Start date: May 1, 2009
• Est. completion date: January 1, 2017

Study information

• Verified date: July 2018
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: January 1, 2017
• Est. primary completion date: December 31, 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid annuloplasty
Tricuspid annuloplasty

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of more than mild tricuspid insufficiency		5 year
Secondary	VO2 max	Physical function capacity measured by VO2 max	1 year
Secondary	Right ventricular function	Right ventricle function at the follow up	5 year