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The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System

NCT02787408 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-10-25

Study results available
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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.

Conditions

  • Tricuspid Valve Regurgitation

Interventions

DEVICE

EW Tricuspid Transcatheter Repair System

Treatment with the EW Tricuspid Transcatheter Repair System

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2018-01-30
Completion
2020-12-14

Countries

  • Canada
  • France
  • Germany
  • Greece
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02787408 on ClinicalTrials.gov