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

September 17, 2025 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 Transcatheter Atrial Shunt System.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Study Type

Interventional

Enrollment (Actual)

71

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 Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego Health
      • San Francisco, California, United States, 94143
        • University California San Francisco
    • Florida
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health - Jacksonville
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Medical Group
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Institute for Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Washington
      • Seattle, Washington, United States, 98122
        • 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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Symptomatic Heart Failure (HF):

    • NYHA class II with a history of > II; III; or ambulatory IV AND
    • ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months prior to study entry.
  • On stable Guideline Directed Medical Therapy (GDMT) for heart failure
  • At rest: elevated LAP (or PCWP) of > 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of > 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by > 10 mmHg
  • Left Ventricular Ejection Fraction (LVEF) ≤ 40%
  • Pulmonary Vascular Resistance (PVR) < 4.0 WU

Exclusion Criteria:

  • Severe HF:

    • Stage D, non-ambulatory NYHA Class IV, transplant list
    • If BMI < 30, Cardiac index < 2.0 L/min/m2
    • If BMI ≥ 30, cardiac index < 1.8 L/min/m2
    • Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
    • LVEF < 20%
  • Valve disease: MR > 3+ or > moderate MS, TR > 2+, AR > 2+ or > moderate AS
  • MI or therapeutic invasive cardiac procedure < 3 months
  • TIA, stroke, CRT implanted < 6 months
  • RV dysfunction > mild by TTE OR TAPSE < 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25%
  • Dialysis OR renal dysfunction (S-CR > 2.5 mg/dl OR eGFR < 25 ml/min/1.73m2)
  • 6MWT < 50m OR > 600m
  • Active endocarditis or infection < 3 months
  • Mean Right Atrial Pressure (mRAP) > 15 mmHg at rest
  • Body Mass Index (BMI) ≥ 45 kg/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 Transcatheter Atrial Shunt System
Device: Transcatheter Atrial Shunt System
Transcatheter treatment of symptomatic left heart failure patients

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, and 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
Change in pulmonary capillary wedge pressure (PCWP) from Baseline to Follow Up
Time Frame: 3 months, 6 months
Change 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

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 (Actual)

December 15, 2023

Study Completion (Estimated)

November 1, 2028

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 (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

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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