Early Feasibility Study - Edwards APTURE Transcatheter Shunt System (ALT-FLOW US)

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Heart Failure

Treatments: Device: Transcatheter Atrial Shunt System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03523416

2018-02

Details and patient eligibility

About

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Full description

The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic Heart Failure (HF):

  • NYHA class II with a history of > II; III; or ambulatory IV AND
  • ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP 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 Guideline Directed Medical Therapy (GDMT) for heart failure

• At rest: elevated LAP (or PCWP) of > 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of > 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by > 10 mmHg

• Left Ventricular Ejection Fraction (LVEF) ≤ 40%

• Pulmonary Vascular Resistance (PVR) < 4.0 WU

Exclusion criteria

• Severe HF:

  • Stage D, non-ambulatory NYHA Class IV, transplant list
  • If BMI < 30, Cardiac index < 2.0 L/min/m2
  • If BMI ≥ 30, cardiac index < 1.8 L/min/m2
  • Left Ventricular End-Diastolic Diameter (LVEDD) > 8 cm
  • LVEF < 20%

• Valve disease: MR > 3+ or > moderate MS, TR > 2+, 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 > 2.5 mg/dl OR eGFR < 25 ml/min/1.73m2)

• 6MWT < 50m OR > 600m

• Active endocarditis or infection < 3 months

• Mean Right Atrial Pressure (mRAP) > 15 mmHg at rest

• 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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71 participants in 1 patient group

Edwards Transcatheter Atrial Shunt System

Experimental group

Treatment:

Device: Transcatheter Atrial Shunt System