Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: APTURE transcatheter shunt

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Symptomatic HF:

  • NYHA II w/ history of > II; III; or ambulatory IV AND
  • ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP 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 GDMT for HF
• Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist

• Hemodynamic criteria

  o At rest: Elevated LAP (or PCWP) > 15 mmHg AND LAP > RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) > 25 mmHg AND LAP > RAP + 10 mmHg

• Pulmonary Vascular Resistance (PVR) < 5.0 WU as determined by site cardiologist

Exclusion Criteria

• Severe HF:

  • NYHA IV, stage D, non-ambulatory, transplant list
  • Cardiac index ≤ 1.5 L/min/m2
  • Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
  • LVEF <20%

• Valve disease

  • MR >3+ or > moderate MS, TR >3+ (severe on 5-point scale), 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 > 220 micromol/L OR e-GFR < 25ml/min/1.73 m2)
• 6MWT <50m OR >400m
• Active endocarditis or infection < 3 months
• Mean Right Atrial Pressure (mRAP) > 15 mmHg as determined by site cardiologist
• Body Mass Index (BMI) ≥ 45 kg/m2

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Edwards APTURE transcatheter shunt system	Device: APTURE transcatheter shunt; 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)	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)	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)	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)	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	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	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	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	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	Change in two parameters from Baseline to Follow Up (3Month, 6Month): "TAPSE", Tricuspid Annular Plane Excursion; "TAPSE/sPAP", Tricuspid Annular Plane Excursion (TAPSE) divided by the systolic pulmonary Artery Pressure (sPAP)	3 Months, 6 Months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): November 3, 2023
• Study Completion (Estimated): November 11, 2028

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2018-11

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.: Yes