CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
EW Tricuspid Transcatheter Repair Systemdevice
Likely dose
Edwards TricuSPid TrAnsCatheter REpaiR System (device; sizes include 9 mm, 12 mm, and 15 mm)AI-extracted
Key inclusion· 5
  • ✓Age 18 or older
  • ✓Symptomatic tricuspid regurgitation (NYHA Class II or greater) requiring repair or replacement, as assessed by the Heart Team
  • ✓Functional (not primary structural) tricuspid regurgitation as the primary etiology
  • ✓Determined by the Heart Team (minimum one Cardiologist and one Cardiac Surgeon) to be at high surgical risk, with favorable benefit-risk analysis for the investigational device
Key exclusion· 26
  • ✕Native tricuspid annulus area below minimum device requirements: <2.14 cm² (9 mm), <2.63 cm² (12 mm), or <3.27 cm² (15 mm)
  • ✕Sub-valvular anatomy precluding proper anchor, coaptation, positioning, or retrieval
  • ✕Access pathway vessel diameter <7.1 mm
  • ✕Moderate or greater tricuspid valve stenosis

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

Search/NCT02787408
NCT02787408N/ACompleted
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The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

Edwards Lifesciences·interventional·Posted Jun 1, 2016·Updated Oct 25, 2022

In Brief

A clinical study evaluating EW Tricuspid Transcatheter Repair System for Tricuspid Valve Regurgitation. Completed, enrolled 25 participants across 11 sites in 5 countries.

Detailed Summary

The purpose of the study is to assess the safety and device performance of the Edwards Tricuspid Transcatheter Repair System in patients with clinically significant, symptomatic, tricuspid regurgitation who are at high surgical risk for standard tricuspid repair/replacement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTricuspid Valve Regurgitation
CountriesCanada, France, Germany, Greece, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 1, 2016
Enrollment StartSep 14, 2016
Primary CompletionJan 30, 2018
Study CompletionDec 14, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.1 years ago

Interventions

EW Tricuspid Transcatheter Repair Systemdevice

Treatment with the EW Tricuspid Transcatheter Repair System