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NCT05686317 · ClinicalTrials.gov registry record · NA
ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
A NA study of Heart Failure, sponsored by Edwards Lifesciences.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05686317: Active NA study of Heart Failure, sponsored by Edwards Lifesciences.
NCT05686317 is a NA study of Heart Failure that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 100 participants, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05686317, a NA study of Heart Failure, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
Primary Outcome
Shunt implant safety: proportion of patients in the APTURE shunt group without any serious device or procedure-related (CEC adjudicated) complications (i.e., Major Adverse Cardiovascular, Cerebrovascular, and Renal Events \[MACCRE\]; at 30 days post index procedure or hospital discharge, whichever is later.
Conditions Studied
Interventions
- DEVICE Edwards APTURE transcatheter shunt system
- DIAGNOSTIC_TEST Sham procedure
Study Locations (20)
California
- University of California Irvine - Irvine
- University of California San Diego - La Jolla
- Scripps Health - La Jolla
- University of Southern California - Los Angeles
- University of California San Francisco - San Francisco
Minnesota
- Abbott Northwestern Hospital - Minneapolis
- Mayo Clinic - Rochester
New York
- St. Francis Hospital & Heart Center - Roslyn
- Montefiore Medical Center - The Bronx
Ohio
- The Christ Hospital - Cincinnati
- The Ohio State University - Columbus
Illinois
- Ascension Illinois Heart and Vascular Medical Group - Elk Grove
Kansas
- Kansas University Medical Center - Kansas City
Oklahoma
- Oklahoma Heart Institute - Tulsa
Oregon
- Oregon Health and Science University - Oregon City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2030-08-31 |
| Phase | NA |
What the registry record for NCT05686317 still lists
NCT05686317 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 2,049-participant average among 397 other Heart Failure trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 2 interventions - of which Edwards APTURE transcatheter shunt system is the first listed.
NCT05686317 names 20 study sites across 13 states, led by California, Minnesota, New York.
Frequently Asked Questions
What is clinical trial NCT05686317 about?
NCT05686317 is a clinical study titled "ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System". This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
What is the current status of trial NCT05686317?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2023-04-01. Estimated completion is 2030-08-31.
What conditions does trial NCT05686317 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT05686317?
The interventions under investigation include: Edwards APTURE transcatheter shunt system (DEVICE), Sham procedure (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05686317?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05686317 being conducted?
This trial has 20 study locations across California, Illinois, Kansas, Minnesota, New York. 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 NCT05686317's enrollment target sits among peer trials
100 212th of 397 higher than 177 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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