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ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

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

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

NCT05686317•Edwards Lifesciences

View on ClinicalTrials.gov

Summary

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

Detailed Description

The objectives of this trial are to assess the safety, performance, and effectiveness of the Edwards APTURE transcatheter shunt system when used for the treatment of patients with heart failure with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction (LVEF \>40%) who remain symptomatic despite guideline-directed medical therapy (GDMT)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Symptomatic heart failure
•1. A primary diagnosis of HFmrEF or HFpEF (LVEF \> 40%), and
•2. NYHA class II to ambulatory NYHA class IV (IVa), and
•3. Documentation of at least one of the following from the date of initial informed consent or date of enrollment:
•i. Within the prior 12 months, EITHER:
•HF hospital admission (with HF as the primary or secondary diagnosis)
•Treatment with intravenous (IV) or intensification of oral diuretics for HF
•ii. Within the prior 6 months, EITHER:
•BNP value \> 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation (AF)
•BNP \> 125 pg/ml for permanent or long-term persistent AF
+2 more criteria

Exclusion Criteria

•Severe heart failure defined as one or more of the below:
•1. ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF
•2. If Body Mass Index (BMI) \< 30, cardiac index \< 2.0 L/min/m2
•3. If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
•4. Inotropic infusion (continuous or intermittent) within the past 6 months
•5. Patient is on the cardiac transplant waiting list
•6. Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to \> 40%
•Valve disease:
•1. Degenerative mitral regurgitation \> moderate
•2. Functional or secondary mitral valve regurgitation defined as grade \> moderate
+16 more criteria

Locations (28)

University of California Irvine

Irvine, California, United States

University of California San Diego

La Jolla, California, United States

Scripps Health

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Ascension Illinois Heart and Vascular Medical Group

Elk Grove, Illinois, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Francis Hospital & Heart Center

Roslyn, New York, United States

Key Dates

Start Date

April 1, 2023

Primary Completion Date

November 1, 2026

Completion Date

August 31, 2030

Last Updated

March 13, 2026

Enrollment

100

ESTIMATED participants

Conditions

Heart Failure

Interventions

Edwards APTURE transcatheter shunt system

DEVICE

Sham procedure

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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