Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

Terminated

• Conditions: Tricuspid (Valve); Deformity
• Interventions: Procedure: Mitral Valve Annuloplasty

• Registration Number: NCT02357862
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The purpose of this study is to evaluate the impact of isolated mitral valve annuloplasty on the geometry and the function of the tricuspid valve complex.

Detailed Description

The proposed pathogenesis of functional tricuspid regurgitation (TR) in mitral valve disease seems incomplete. Because both atrioventricular valves are closely connected to each other by means of the cardiac fibrous skeleton, the geometry of the tricuspid valve is likely to be distorted after ring-annuloplasty of the mitral valve. This could lead to the development of functional TR, or to an increase in TR severity. To test this hypothesis, a prospective study will be started in patients undergoing isolated mitral valve annuloplasty.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Status Verified: 2015-07
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty

Exclusion Criteria

• concomitant tricuspid valve surgery
• atrial fibrillation at the moment of surgery
• poor echocardiographic windows

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitral Valve Annuloplasty	Mitral Valve Annuloplasty	All eligible patients

Primary Outcome Measures

Name	Time	Method
Postoperative geometric changes in tricuspid valve annulus (TA)	day 0	Measurement of changes in 3D descriptors of the TA (e.g. changes from baseline in the TA area of the best-fit plane in cm\^2, and changes from baseline in the height of each TA point to the TA best-fit plane in mm)