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Heart FailureALT-FLOW USNCT03523416

Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

A study testing Edwards APTURE transcatheter shunt system in people with Heart Failure, run by Edwards Lifesciences at 19 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Edwards APTURE transcatheter shunt system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
19 sitesUnited States
Study dates
31 Jul 2018to Apr 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Refined HFrEF Subgroup Inclusion Criteria:

  • A primary diagnosis of HFrEF (LVEF ≤ 40%), and
  • NYHA Class II, III, or IVa heart failure symptoms and
  • Documentation of at least one of the following in the past 12 months, such as:
  • Hospitalization for heart failure; or
  • Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
  • Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.

Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.

  • Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)

Refined HFrEF Subgroup Exclusion Criteria:

  • Severe HF defined as one or more of the following:
  • Ambulatory NT-proBNP value >5,000 pg/ml or BNP value >1,600 pg/ml
  • Left ventricular end-diastolic diameter (LVEDD) >8 cm
  • Left ventricular ejection fraction (LVEF) < 20%
  • ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
  • Inotropic infusion (continuous or intermittent) within the past 6 months
  • Active listing on the cardiac transplant waiting list
  • More than mild right ventricular dysfunction
  • Valve disease
  • Mitral regurgitation > moderate
  • Mitral stenosis > mild
  • Tricuspid regurgitation > moderate
  • Aortic regurgitation > moderate
  • Aortic stenosis > moderate
  • Body mass index (BMI) ≥45
  • Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization
  • Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months
  • Cardiac resynchronization therapy implanted within the past 12 months
  • Renal insufficiency as determined by serum creatinine (sCr) level >2.5 mg/dL or estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2
  • Performance of the 6-minute walk test with a distance <100 m or >450 m
  • Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure
  • Presence of one or more of the following resting hemodynamic findings:
  1. Mean pulmonary capillary wedge pressure (PCWP) >35 mmHg
  2. Mean right atrial pressure (RAP) >15 mmHg
  3. Mean PCWP-mean RAP gradient < 5 mmHg
  4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
  5. Cardiac index <1.8 L/min/m2

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Natalie Alon contact

949-250-1898

Natalie_Alon@edwards.com

Melissa Arteaga contact

949-250-2002

melissa_arteaga@edwards.com

19 sites in 1 country

United States19 sites, 2 recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Withdrawn

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    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

    Elizabeth Eberle, 614-293-7464, Elizabeth.Eberle@osumc.edu

    Annie Kellum, 614-366-8848, Annie.Kellum@osumc.edu

    Recruiting

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46260

    Completed

  • University of Florida Health - Jacksonville

    Jacksonville, Florida, 32209

    Active, not recruiting

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

    Active, not recruiting

  • UC San Diego Health

    La Jolla, California, 92037

    Active, not recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

    Withdrawn

  • Abbott Northwestern

    Minneapolis, Minnesota, 55407

    Active, not recruiting

  • Morristown Medical Center

    Morristown, New Jersey, 07960

    Withdrawn

  • Oregon Health and Science University

    Portland, Oregon, 97239

    Active, not recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Active, not recruiting

  • University California San Francisco

    San Francisco, California, 94143

    Active, not recruiting

  • Swedish Medical Center

    Seattle, Washington, 98122

    Active, not recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Active, not recruiting

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

    Tamara Morton, 918-574-9223, tamara.morton@hillcrest.com

    Allyson O'Guin, 918-574-9253, allyson.oguin@hillcrest.com

    Recruiting

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

    Completed

Other trials in United States

About this study

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

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

Read the detailed description

The early feasibility study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

Conditions
Heart Failure
Being tested
Edwards APTURE transcatheter shunt system
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Edwards APTURE transcatheter shunt systemDevice

    Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure.

Study groups in NCT03523416
Study groupRoleWhat they receive
Edwards APTURE transcatheter shunt systemExperimentalNot described
Receives: Device: Edwards APTURE transcatheter shunt system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)

    Composite of major adverse cardiac, cerebrovascular, renal events (MACCRE) and re-intervention for study device related complications at 30 days.

    Measured: 30 days

Secondary outcomes (8)

  1. Rate at which device is successfully implanted (Device Success)

    Device is deployed as intended and the delivery system is successfully removed as intended at the time of the patient's exit from the implant procedure room.

    Measured: Day 0

  2. Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)

    Device success with evidence of shunt patency and hospital discharge without the need for additional surgical or percutaneous intervention related to the study device including unacceptable Qp/Qs values.

    Measured: 10 days post-op

  3. Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)

    Procedural success without major adverse cardiac, cerebrovascular, renal events (MACCRE), and re-intervention for study device related complications at 30 days.

    Measured: 30 days

  4. Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up

    Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month)

    Measured: 3 months, 6 months

  5. Improvement in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up

    Improvement in PCWP value from Baseline to Follow Up (3Month, 6Month)

    Measured: 3 months, 6 months

  6. Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up

    Change in PAP and RAP values from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)

    Measured: 3 months, 6 months

  7. Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up

    Change in PVR value from Baseline to Follow Up (3Month, 6Month) under the same test conditions (e.g. comparison in the value at rest at baseline, to at rest at follow up; comparison in the value at exercise at baseline, to at exercise at follow up)

    Measured: 3 months, 6 months

  8. Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up

    Change in two parameters from Baseline to Follow Up (3Month, 6Month): 1. "TAPSE", Tricuspid Annular Plane Excursion 2. "TAPSE/sPAP", Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP)

    Measured: 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2018
  2. Study start31 Jul 2018
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03523416
Sponsor's protocol ID
2018-02
Acronym
ALT-FLOW US
Status last verified
Sep 2026
First submitted
12 Apr 2018
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Fioretti F, Hibbert B, Eckman PM, Simard T, Labinaz M, Nazer B, Wiley M, Gupta B, Sauer AJ, Shah H, Sorajja P, Pineda AM, Missov E, Aldaia L, Koulogiannis K, Gray WA, Zahr F, Butler J. Left Atrial-to-Coronary Sinus Shunting in Heart Failure With Mildly Reduced or Preserved Ejection Fraction: The ALT-FLOW Trial (Early Feasibility Study) 2-Year Results. JACC Heart Fail. 2025 Jun;13(6):987-999. doi: 10.1016/j.jchf.2025.02.003. Epub 2025 Feb 11.

    PubMed 40019407

Questions about this trial

What is this clinical trial studying?

A study testing Edwards APTURE transcatheter shunt system in people with Heart Failure, run by Edwards Lifesciences at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Natalie Alon (949-250-1898, Natalie_Alon@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint) (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03523416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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