Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

Université Catholique de Louvain

Status: Completed

Conditions: Tricuspid Valve Insufficiency

Treatments: Procedure: Tricuspid annuloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03604484

UCLSaint Luc

Details and patient eligibility

About

Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Tricuspid annuloplasty

Active Comparator group

Description:

Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery

Treatment:

Procedure: Tricuspid annuloplasty

No Tricuspid annuloplasty

No Intervention group

Description:

Control patients