Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

NCT ID: NCT01580436

Last Updated: 2014-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tricuspid Valve Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tricuspid Valve Annuloplasty

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

Group Type EXPERIMENTAL

Tricuspid Valve Annuloplasty

Intervention Type PROCEDURE

Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery

Conservative arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tricuspid Valve Annuloplasty

Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Wilfried Mullens, MD PhD

Professor Cardiovascular Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ziekenhuis Oost-Limburg (General Hospital Genk)

Genk, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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David Verhaert, MD

Role: CONTACT

+32 089 32 70 91

Chris Beerts

Role: CONTACT

+32 089 32 71 91

Facility Contacts

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David Verhaert, MD

Role: primary

+32 089 32 70 91

Chris Beerts

Role: backup

+32 089 32 71 91

Other Identifiers

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TVP Study

Identifier Type: -

Identifier Source: org_study_id

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