Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)
NCT ID: NCT04000607
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
45 participants
INTERVENTIONAL
2019-07-10
2028-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Edwards APTURE transcatheter shunt system
APTURE transcatheter shunt
Transcatheter treatment of symptomatic left heart failure patients
Interventions
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APTURE transcatheter shunt
Transcatheter treatment of symptomatic left heart failure patients
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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2018-11
Identifier Type: -
Identifier Source: org_study_id
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