NCT02357862

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

May 8, 2018

Status Verified

July 1, 2015

Enrollment Period

1.1 years

First QC Date

January 26, 2015

Last Update Submit

May 2, 2018

Conditions

Tricuspid (Valve); Deformity

Keywords

Cardiovascular DiseasesHeart Valve DiseasesMitral Valve AnnuloplastyTricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Postoperative geometric changes in tricuspid valve annulus (TA)

    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)

    day 0

Study Arms (1)

Mitral Valve Annuloplasty

All eligible patients

Procedure: Mitral Valve Annuloplasty

Interventions

Mitral Valve AnnuloplastyPROCEDURE

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

Mitral Valve Annuloplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing minimally invasive, isolated mitral valve annuloplasty in the University Hospitals Leuven

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Congenital AbnormalitiesCardiovascular DiseasesHeart Valve DiseasesTricuspid Valve Insufficiency

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve AnnuloplastyCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Werner Budts, M.D., PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 6, 2015

Study Start

January 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

May 8, 2018

Record last verified: 2015-07