ExplorATory Study oF the EdWards Transcatheter Atrial Shunt System (AlT FloW Germany)
NCT04965623 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2024-09-19
Summary
The Exploratory Study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Conditions
Interventions
- DEVICE
-
Atrial Shunt
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
- 2021-02-22
- Primary Completion
- 2023-12-06
- Completion
- 2023-12-06
- FDA Device
- Yes
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