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ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System
NCT05686317 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05686317
The ClinicalTrials.gov registry entry for NCT05686317 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05686317 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Minnesota, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05686317?
The interventions under investigation include: Edwards APTURE transcatheter shunt system (DEVICE), Sham procedure (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05686317?
This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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