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

September 29, 2026 updated by: Edwards Lifesciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • 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 Backup

Study Locations

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        • Withdrawn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        • Withdrawn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        • Withdrawn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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Edwards APTURE transcatheter shunt system
Device: Edwards APTURE transcatheter shunt system

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of major cardiac/cerebrovascular/renal events and re-intervention (Safety Endpoint)
Time Frame: 30 days

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate at which device is successfully implanted (Device Success)
Time Frame: Day 0

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.
Day 0
Rate at which device is patent and subject is discharged from hospital without the need for additional intervention for the device (Procedural Success)
Time Frame: 10 days post-op

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.
10 days post-op
Rate at which the procedure is successful without major cardiac/cerebrovascular/renal events and re-intervention (Clinical Success)
Time Frame: 30 days

Procedural success without major adverse cardiac, cerebrovascular, renal events (MACCRE), and re-intervention for study device related complications at 30 days.
30 days
Change in the ratio of systemic blood flow (Qs) to the pulmonary blood flow (Qp), called "Qp/Qs", from Baseline to Follow Up
Time Frame: 3 months, 6 months

Change in Qp/Qs value from Baseline to Follow Up (3Month, 6Month)
3 months, 6 months
Improvement in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up
Time Frame: 3 months, 6 months

Improvement in PCWP value from Baseline to Follow Up (3Month, 6Month)
3 months, 6 months
Change in mean systolic & diastolic pulmonary artery pressure (PAP) and change in mean right atrial pressure (RAP) from Baseline to Follow Up
Time Frame: 3 months, 6 months

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)
3 months, 6 months
Change in Pulmonary Vascular Resistance (PVR) from Baseline to Follow Up
Time Frame: 3 months, 6 months

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)
3 months, 6 months
Change in two parameters related to Tricuspid Annular Plane Excursion (TAPSE) from Baseline to Follow Up
Time Frame: 3 months, 6 months

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)
3 months, 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HFrEF Subgroup Analysis
Time Frame: 10 days post-op, 30 days, 3 months, 6 months

Data obtained from the refined HFrEF subgroup will be analyzed according to the endpoints defined above, based on measurements available across all follow-up time points.
10 days post-op, 30 days, 3 months, 6 months

Collaborators and Investigators

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

Sponsor

Edwards Lifesciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 31, 2018

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2032

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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