Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

ClinicalTrials.gov ID: NCT03523416

Public ClinicalTrials.gov record NCT03523416. 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.

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Official title

Early Feasibility Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)

Brief summary

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

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.

Study identification

NCT ID: NCT03523416
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Edwards Lifesciences; Industry
Enrollment: 90 participants

Conditions and interventions

Conditions

Heart Failure

Interventions

Edwards APTURE transcatheter shunt system Device

Device

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: Jul 31, 2018 (Actual)
Primary completion: Apr 2027 (Estimated)
Completion: Apr 2032 (Estimated)
Last update posted: Oct 2, 2026

2018 – 2032

United States locations

U.S. sites: 19
U.S. states: 15
U.S. cities: 19

Facility	City	State	ZIP	Site status
UC San Diego Health	La Jolla	California	92037	Active, not recruiting
Cedars Sinai Medical Center	Los Angeles	California	90048	Withdrawn
University California San Francisco	San Francisco	California	94143	Active, not recruiting
University of Colorado	Aurora	Colorado	80045	Withdrawn
University of Florida Health - Jacksonville	Jacksonville	Florida	32209	Active, not recruiting
St. Vincent Medical Group	Indianapolis	Indiana	46260	Completed
Kansas University Medical Center	Kansas City	Kansas	66160	Active, not recruiting
Abbott Northwestern	Minneapolis	Minnesota	55407	Active, not recruiting
Mayo Clinic	Rochester	Minnesota	55905	Active, not recruiting
Morristown Medical Center	Morristown	New Jersey	07960	Withdrawn
Montefiore Medical Center	The Bronx	New York	10467	Active, not recruiting
Atrium Health	Charlotte	North Carolina	28203	Completed
The Christ Hospital	Cincinnati	Ohio	45219	Active, not recruiting
The Ohio State University Medical Center	Columbus	Ohio	43210	Recruiting
Oklahoma Heart Institute	Tulsa	Oklahoma	74104	Recruiting
Oregon Health and Science University	Portland	Oregon	97239	Active, not recruiting
Lankenau Institute for Medical Research	Wynnewood	Pennsylvania	19096	Completed
Medical University of South Carolina	Charleston	South Carolina	29425	Active, not recruiting
Swedish Medical Center	Seattle	Washington	98122	Active, not recruiting

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

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03523416, 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 Oct 2, 2026 · Synced Nov 6, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT03523416 live on ClinicalTrials.gov.

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