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Completed

NCT Number: NCT03604484

Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery

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

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Key information

Conditions

Tricuspid Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tricuspid annuloplasty

Procedure

Tricuspid annuloplasty

Primary outcomes

  1. Incidence of more than mild tricuspid insufficiency

    Time frame: 5 year

Secondary outcomes

  1. VO2 max

    Time frame: 1 year

    Physical function capacity measured by VO2 max

  2. Right ventricular function

    Time frame: 5 year

    Right ventricle function at the follow up

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2017
First posted
Jul 27, 2018
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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