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Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Primary Purpose

Tricuspid Valve Insufficiency

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Tricuspid Valve Annuloplasty

About this trial

This is an interventional treatment trial for Tricuspid Valve Insufficiency focused on measuring Tricuspid Valve Insufficiency, Cardiac Valve Annuloplasty, Outcome Assessment (Health Care)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ziekenhuis Oost-Limburg (General Hospital Genk)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tricuspid Valve Annuloplasty

Conservative arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

combination of all-cause mortality or heart failure hospitalisation

Secondary Outcome Measures

RV function & geometry

volumes and ejection fraction Assessed by cardiac ultrasound and MRI

Quality of Life

Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.

Duration of Hospital and ICU stay

All-Cause Mortality

Hospitalization for Heart Failure

progressive TR > 2+ post-surgery

cardiovascular mortality

Exercise Tolerance

Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)

Full Information

NCT ID

NCT01580436

First Posted

October 18, 2011

Last Updated

October 23, 2014

Sponsor

Hasselt University

1. Study Identification

Unique Protocol Identification Number

NCT01580436

Brief Title

Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Official Title

Prospective, Randomized Evaluation of Prophylactic Tricuspid Valve Annuloplasty in Patients Undergoing Mitral Valve Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tricuspid Valve Insufficiency

Keywords

Tricuspid Valve Insufficiency, Cardiac Valve Annuloplasty, Outcome Assessment (Health Care)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tricuspid Valve Annuloplasty

Arm Type

Experimental

Arm Description

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

Arm Title

Conservative arm

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Tricuspid Valve Annuloplasty

Intervention Description

Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery

Primary Outcome Measure Information:

Title

combination of all-cause mortality or heart failure hospitalisation

Time Frame

at 12 months post-surgery

Secondary Outcome Measure Information:

Title

RV function & geometry

Description

volumes and ejection fraction Assessed by cardiac ultrasound and MRI

Time Frame

3, 6, 12 and 18 months

Title

Quality of Life

Description

Change at follow-up, measured by SF-36 & Minnesota Living with Heart Failure scale.

Time Frame

6, 12 and 18 months

Title

Duration of Hospital and ICU stay

Time Frame

postoperative phase

Title

All-Cause Mortality

Time Frame

at 3, 6, 12 and 18 months post-surgery

Title

Hospitalization for Heart Failure

Time Frame

at 3, 6, 12 and 18 months post-surgery

Title

progressive TR > 2+ post-surgery

Time Frame

3, 6, 12 and 18 months

Title

cardiovascular mortality

Time Frame

at 3, 6, 12 and 18 months post-surgery

Title

Exercise Tolerance

Description

Change at follow-up, by 6-minute walking distance and maximal exercise cyclo-ergometry (maximal aerobic capacity)

Time Frame

6, 12 and 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Verhaert, MD

Phone

+32 089 32 70 91

david.verhaert@zol.be

First Name & Middle Initial & Last Name or Official Title & Degree

Chris Beerts

Phone

+32 089 32 71 91

chris.beerts@zol.be

Facility Information:

Facility Name

Ziekenhuis Oost-Limburg (General Hospital Genk)

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Individual Site Status

Recruiting

Facility Contact: