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

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: APTURE transcatheter shunt

Study type: Interventional

Funder types: Industry

Identifiers

NCT04000607

2018-11

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Edwards APTURE transcatheter shunt system

Experimental group

Treatment:

Device: APTURE transcatheter shunt