Clinical Trial

Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Study acronym: ALT-FLOW US
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2018-05-01; most recent amendment 2025-09-17.
Status change: Recruiting → Active, Not Recruiting 2024-10-16
Status change: Withheld → Recruiting 2020-04-02
Trial Details
NCT Number NCT03523416
Lead Sponsor Edwards Lifesciences
Conditions Heart Failure
Enrollment 71 participants
Start Date 2018-07-31
Primary Completion 2023-12-15 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2025-09-19