CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
Tricuspid valve repair +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01532921
NCT01532921N/ACompleted
CompareCT.gov

EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

Medtronic Cardiac Rhythm and Heart Failure·observational·Posted Feb 15, 2012·Updated Aug 10, 2018

In Brief

An observational study evaluating Tricuspid valve repair, Left-sided heart surgery, and 1 other intervention for Tricuspid Valve Insufficiency. Completed, enrolled 85 participants across 7 sites in 3 countries.

Detailed Summary

Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsTricuspid Valve Insufficiency
CountriesFrance, Germany, Israel
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2012
Enrollment StartJan 1, 2011
Primary CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 14.4 years ago

Interventions

Tricuspid valve repairprocedure

Left-sided heart surgeryprocedure

Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned

Contour 3D Tricuspid Annuloplasty Ringdevice

Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair