Changes in the Tricuspid Valve Complex Induced by Mitral Valve Annuloplasty

NCT ID: NCT02357862

Last Updated: 2018-05-08

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

TERMINATED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Tricuspid (Valve); Deformity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mitral Valve Annuloplasty

All eligible patients

Mitral Valve Annuloplasty

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Budts, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven - University of Leuven, Department of Cardiovascular Sciences, Division of Cardiology; University Hospitals Leuven, Department of Cardiology

Other Identifiers

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MVR_TV

Identifier Type: -

Identifier Source: org_study_id

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