Trials / Completed
CompletedNCT02787408
The SPACER Trial - Repair of Tricuspid Valve Regurgitation Using the Edwards TricuSPid TrAnsCatheter REpaiR System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. The study is a multi-center, international, prospective, single arm, safety study. Enrolled subjects will be assessed for clinical follow-up at 1 month, 6 months, 1 year and annually for 3 years post implant procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EW Tricuspid Transcatheter Repair System | Treatment with the EW Tricuspid Transcatheter Repair System |
Timeline
- Start date
- 2016-09-14
- Primary completion
- 2018-01-30
- Completion
- 2020-12-14
- First posted
- 2016-06-01
- Last updated
- 2022-10-25
- Results posted
- 2022-10-25
Locations
11 sites across 5 countries: Canada, France, Germany, Greece, Switzerland
Source: ClinicalTrials.gov record NCT02787408. Inclusion in this directory is not an endorsement.