Trials / Completed
CompletedNCT02471807
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.
Detailed description
The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System. Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Edwards FORMA Tricuspid Transcatheter Repair System |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2019-06-01
- Completion
- 2023-01-17
- First posted
- 2015-06-15
- Last updated
- 2023-03-28
- Results posted
- 2022-01-06
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02471807. Inclusion in this directory is not an endorsement.