Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Terminated

CT.gov ID

NCT02357862

Collaborator

(none)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tricuspid (Valve); Deformity	Procedure: Mitral Valve Annuloplasty

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 Design

Study Type:

Observational

Actual Enrollment :

22 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Mitral Valve Annuloplasty on the Tricuspid Valve Complex

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Mitral Valve Annuloplasty All eligible patients	Procedure: Mitral Valve Annuloplasty Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion

Arm

Intervention/Treatment

Mitral Valve Annuloplasty

All eligible patients

Procedure: Mitral Valve Annuloplasty

Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator: Werner Budts, M.D., PhD, KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology