Trials / Active Not Recruiting
Active Not RecruitingNCT03523416
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
Early Feasibility Study Of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Detailed description
The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Atrial Shunt System | Transcatheter treatment of symptomatic left heart failure patients |
Timeline
- Start date
- 2018-07-31
- Primary completion
- 2023-12-15
- Completion
- 2028-11-01
- First posted
- 2018-05-14
- Last updated
- 2025-09-19
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03523416. Inclusion in this directory is not an endorsement.