Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

NCT ID: NCT03604484

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-01
• Study Completion Date: 2017-01-01

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.

Conditions

Tricuspid Valve Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tricuspid annuloplasty

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

Group Type: ACTIVE_COMPARATOR

Tricuspid annuloplasty

Intervention Type: PROCEDURE

Tricuspid annuloplasty

No Tricuspid annuloplasty

Control patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tricuspid annuloplasty

Tricuspid annuloplasty

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Pettinari Matteo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UCLSaint Luc

Identifier Type: -

Identifier Source: org_study_id