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NCT03523416 · ClinicalTrials.gov registry record · NA
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System
A NA study of Heart Failure, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 71
- Enrollment target
- 15
- Study locations
NCT03523416: Active NA study of Heart Failure, sponsored by Edwards Lifesciences.
NCT03523416 is a NA study of Heart Failure that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 71 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03523416, a NA study of Heart Failure, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 71 participants
- Enrollment target
- 15
- Study locations
Study Summary
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Primary Outcome
Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.
Conditions Studied
Interventions
- DEVICE Transcatheter Atrial Shunt System
Study Locations (15)
California
- UC San Diego Health - La Jolla
- University California San Francisco - San Francisco
Minnesota
- Abbott Northwestern - Minneapolis
- Mayo Clinic - Rochester
Ohio
- The Christ Hospital - Cincinnati
- The Ohio State University Medical Center - Columbus
Florida
- University of Florida Health - Jacksonville - Jacksonville
Indiana
- St. Vincent Medical Group - Indianapolis
Kansas
- Kansas University Medical Center - Kansas City
New York
- Montefiore Medical Center - The Bronx
North Carolina
- Atrium Health - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-07-31 |
| Est. Completion | 2028-11 |
| Phase | NA |
What the registry record for NCT03523416 still lists
NCT03523416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Transcatheter Atrial Shunt System is the first listed.
NCT03523416 lists 15 locations in 12 states (California, Minnesota, Ohio).
Frequently Asked Questions
What is clinical trial NCT03523416 about?
NCT03523416 is a clinical study titled "Early Feasibility Study - Edwards APTURE Transcatheter Shunt System". The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.
What is the current status of trial NCT03523416?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 71 participants. The study started on 2018-07-31. Estimated completion is 2028-11.
What conditions does trial NCT03523416 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT03523416?
The interventions under investigation include: Transcatheter Atrial Shunt System (DEVICE).
Who is sponsoring clinical trial NCT03523416?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03523416 being conducted?
This trial has 15 study locations across California, Florida, Indiana, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03523416's enrollment target sits among peer trials
71 243rd of 397 higher than 153 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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