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

June 3, 2026 updated by: Edwards Lifesciences

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-900
        • Instituto do Coracao da Universidade de Sao Paulo
  • Canada
    • Canada
      • Ottawa, Canada, Canada
        • The Ottawa Hospital
  • Germany
      • Bad Oeynhausen, Germany, 32545
        • Herz- und Diabeteszentrum NRW - Bad Oeynhausen
      • Cologne, Germany, 50937
        • Herzzentrum Universitätsklinikum Köln
      • Dresden, Germany, 01307
        • Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg Medizinische Klinik
      • Mainz, Germany, 55131
        • Johannes Gutenberg Universitaet Mainz
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel
  • United States
    • California
      • Irvine, California, United States, 92868
        • University of California Irvine
      • La Jolla, California, United States, 92037
        • Scripps Health
      • La Jolla, California, United States, 92027
        • University of California San Diego
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
    • Illinois
      • Elk Grove, Illinois, United States, 60007
        • Ascension Illinois Heart and Vascular Medical Group
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • New York
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital & Heart Center
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute
    • Oregon
      • Oregon City, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425'
        • Medical University of South Carolina Charleston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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
  • NT-proBNP > 125 pg/ml in NSR or paroxysmal AF
  • NT-proBNP > 375 pg/ml for permanent or long-term persistent AF d. There is objective evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core lab as: As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at ≥ 20 Watts exercise (PCWP ≥ 20W) is elevated to ≥ 25 mmHg and exceeds [the corresponding] right atrial pressure (RAP) by ≥ 8 mmHg • In the judgment of the treating physician and the Central Screening Committee the patient is on GDMT for HFpEF/HFmrEF for >30 days prior to screening and baseline assessments, that is expected to be maintained without change for 6 months.

Key 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
    3. Mitral stenosis > mild
    4. Primary or secondary tricuspid valve regurgitation defined as grade > moderate
    5. Aortic valve disease defined as aortic regurgitation grade > moderate or aortic stenosis > moderate

  • More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters:

    1. Tricuspid annular plane systolic excursion (TAPSE) <1.4 cm, or
    2. RV size ≥ LV size
    3. Right ventricular ejection fraction (RVEF) < 35%; or
    4. Imaging or clinical evidence of congestive hepatopathy
  • Mean right atrial pressure (mRAP) > 15 mmHg at rest
  • Pulmonary vascular resistance (PVR) ≥ 5.0 WU
  • BMI ≥ 45
  • Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular cardiovascular procedure within past 3 months or current indication for coronary revascularization
  • Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months
  • Renal insufficiency as determined by creatinine (sCr) level > 2.5 mg/dL or estimated glomerular filtration rate (eGFR) < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis
  • Performance of the six-minute walk test (6MWT) with a distance < 50m OR > 450m
  • Active endocarditis or infection requiring intravenous antibiotics within 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: APTURE shunt + medical therapy
Device: Edwards APTURE transcatheter shunt system
Treatment with APTURE shunt
Sham Comparator: Sham + medical therapy
Diagnostic test: Sham procedure
CS angiography

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device + Medical Therapy: Subjects with Early Major Adverse Events
Time Frame: 30 days
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.
30 days
Mean change in PCWL from baseline at 6 months
Time Frame: 6-months
Hemodynamic Effectiveness: change in pulmonary capillary wedge during load (PCWL, mmHg/W/kg) from baseline at 6 months.
6-months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of individual patient success defined as being free from death, disabling stroke, and HF hospitalization with at least (≥) a 15-point improvement from baseline KCCQ-OSS or at least (≥) a 25m improvement from baseline 6MWT.
Time Frame: 6-months
6-months
KCCQ-OSS change from baseline at 6-month follow-up
Time Frame: 6-months
Change in Kansas City Cardiomyopathy Questionnaire - Overall Summary Score (KCCQ-OSS) from baseline at 6-month follow-up.
6-months
6MWT change from baseline at 6-month follow-up
Time Frame: 6-months
Chang in 6-Minute Walk Test (6MWT) from baseline at 6-month follow-up
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Edwards Lifesciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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