Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Hasselt University

Status: Unknown

Conditions: Tricuspid Valve Insufficiency

Treatments: Procedure: Tricuspid Valve Annuloplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01580436

TVP Study

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for mitral valve surgery
• Tricuspid Annular diameter > 40mm or >21mm/m²

Exclusion criteria

• Tricuspid Regurgitation more than 2+
• Unable to provide informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Tricuspid Valve Annuloplasty

Experimental group

Description:

Patients, undergoing mitral valve surgery with no significant tricuspid valve regurgitation despite tricuspid annular dilation, randomized to concomitant tricuspid valve annuloplasty.

Treatment:

Procedure: Tricuspid Valve Annuloplasty

Conservative arm

No Intervention group

Description:

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.