Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
NCT03523416 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2025-09-19
Summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Conditions
Interventions
- DEVICE
-
Transcatheter Atrial Shunt System
Transcatheter treatment of symptomatic left heart failure patients
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
- 2018-07-31
- Primary Completion
- 2023-12-15
- Completion
- 2028-11-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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