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Clinical Trials in Canada / NCT04000607
Active, not recruiting Not applicable

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

NCT04000607 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2019-07-10
Last updated
2026-01-27

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

APTURE transcatheter shunt

APTURE transcatheter shunt: Transcatheter treatment of symptomatic left heart failure patients

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of Ottawa Heart Institute Ottawa Ontario
St. Michael's Hospital Toronto Ontario

More Edwards Lifesciences trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04000607 on ClinicalTrials.gov ↗ ← All trials in Canada