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

Edwards Lifesciences

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Edwards APTURE transcatheter 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 APTURE transcatheter shunt system.

Full description

The early feasibility study of the Edwards APTURE transcatheter shunt system (APTURE system) is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the APTURE system.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Refined HFrEF Subgroup Inclusion Criteria:

• A primary diagnosis of HFrEF (LVEF ≤ 40%), and

• NYHA Class II, III, or IVa heart failure symptoms and

• Documentation of at least one of the following in the past 12 months, such as:

  • Hospitalization for heart failure; or
  • Increased treatment for heart failure, including intravenous (IV) or higher-dose diuretic therapy.
  • Elevated heart failure biomarker levels (BNP or NT-proBNP) within the past 6 months.

Note: Participants with NYHA Class II symptoms must have both a recent heart failure worsening event and elevated biomarker levels. Participants with NYHA Class III or IVa symptoms must have either a recent heart failure worsening event or elevated biomarker levels.

• Stable Optimized GDMT - Maintained 6 months post-implant (includes stable GLP-1 RA)

Refined HFrEF Subgroup Exclusion Criteria:

• Severe HF defined as one or more of the following:

  • Ambulatory NT-proBNP value >5,000 pg/ml or BNP value >1,600 pg/ml
  • Left ventricular end-diastolic diameter (LVEDD) >8 cm
  • Left ventricular ejection fraction (LVEF) < 20%
  • ACC/AHA Stage D HF or non-ambulatory NYHA Class IV HF
  • Inotropic infusion (continuous or intermittent) within the past 6 months
  • Active listing on the cardiac transplant waiting list

• More than mild right ventricular dysfunction

• Valve disease

  • Mitral regurgitation > moderate
  • Mitral stenosis > mild
  • Tricuspid regurgitation > moderate
  • Aortic regurgitation > moderate
  • Aortic stenosis > moderate

• Body mass index (BMI) ≥45

• Myocardial infarction and/or any therapeutic invasive, non-valvular cardiac procedure within the past 3 months, or current indication for coronary revascularization

• Stroke, transient ischemic attack, deep vein thrombosis, or pulmonary embolus within the past 6 months

• Cardiac resynchronization therapy implanted within the past 12 months

• Renal insufficiency as determined by serum creatinine (sCr) level >2.5 mg/dL or estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2

• Performance of the 6-minute walk test with a distance <100 m or >450 m

• Active endocarditis or infection requiring intravenous antibiotics within 3 months of scheduled index procedure

• Presence of one or more of the following resting hemodynamic findings:

  1. Mean pulmonary capillary wedge pressure (PCWP) >35 mmHg
  2. Mean right atrial pressure (RAP) >15 mmHg
  3. Mean PCWP-mean RAP gradient < 5 mmHg
  4. Pulmonary vascular resistance (PVR) ≥5 Wood Units (WU)
  5. Cardiac index <1.8 L/min/m2

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Edwards APTURE transcatheter shunt system

Experimental group

Treatment:

Device: Edwards APTURE transcatheter shunt system