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Active, not recruiting Not applicable Interventional

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

ClinicalTrials.gov ID: NCT05686317

Public ClinicalTrials.gov record NCT05686317. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 28, 2026, 6:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Sham-controlled Clinical Trial for Evaluation of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW II)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

Study identification

NCT ID
NCT05686317
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Edwards Lifesciences
Industry
Enrollment
100 participants

Conditions and interventions

Conditions

Interventions

Device · Diagnostic Test

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 1, 2023 (Actual)
Primary completion
Nov 1, 2026 (Estimated)
Completion
Aug 31, 2030 (Estimated)
Last update posted
Jun 4, 2026

2023 – 2030

United States locations

U.S. sites
17
U.S. states
10
U.S. cities
16
Facility City State ZIP Site status
University of California Irvine Irvine California 92868 —
University of California San Diego La Jolla California 92027 —
Scripps Health La Jolla California 92037 —
University of Southern California Los Angeles California 90033 —
University of California San Francisco San Francisco California 94143 —
Ascension Illinois Heart and Vascular Medical Group Elk Grove Illinois 60007 —
Kansas University Medical Center Kansas City Kansas 66160 —
Abbott Northwestern Hospital Minneapolis Minnesota 55407 —
Mayo Clinic Rochester Minnesota 55902 —
St. Francis Hospital & Heart Center Roslyn New York 11576 —
Montefiore Medical Center The Bronx New York 10467 —
The Christ Hospital Cincinnati Ohio 45219 —
The Ohio State University Columbus Ohio 43210 —
Oklahoma Heart Institute Tulsa Oklahoma 74104 —
Oregon Health and Science University Oregon City Oregon 97239 —
Lankenau Medical Center Wynnewood Pennsylvania 19096 —
Medical University of South Carolina Charleston Charleston South Carolina 29425' —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05686317, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 4, 2026 · Synced Oct 28, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05686317 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →