NCT04000607Active, not recruiting
Exploratory Study of the Edwards APTURE Transcatheter Shunt System (ALT-FLOW Canada)
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 45 (actual)
- First submitted
- 24 Jun 2019
- Start date
- 10 Jul 2019
- Primary completion date
- 3 Nov 2023
- Lead sponsor
- Edwards Lifesciences
- Diseases
- Heart failure
- NCT number
- NCT04000607
What you commit to
- Study type: Interventional
- Participants enrolled: 45
- From 10 Jul 2019 to the primary completion date, 3 Nov 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Active endocarditis or infection \< 3 months
Lab values
- 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%
- Dialysis OR renal dysfunction (S-Cr \> 220 micromol/L OR e-GFR \< 25ml/min/1.73 m2)
Other
- RV dysfunction \> mild by TTE OR TAPSE \<1.2 OR RV size ≥ LV size by TTE, OR Right Ventricular Fractional Area Change (RVFAC) ≤ 25%
- 6MWT \<50m OR \>400m
- Mean Right Atrial Pressure (mRAP) \> 15 mmHg as determined by site cardiologist
- Body Mass Index (BMI) ≥ 45 kg/m2
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.