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NCT03523416NARecruiting

Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Edwards Lifesciences

Start Date

7/31/2018

Completion Date

4/1/2032

Summary

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards APTURE transcatheter shunt system.

Detailed 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Edwards APTURE transcatheter shunt system

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Conditions

Heart Failure

Locations

UC San Diego Health

La Jolla, California 92037

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

University California San Francisco

San Francisco, California 94143

United States

University of Colorado

Aurora, Colorado 80045

United States

University of Florida Health - Jacksonville

Jacksonville, Florida 32209

United States

St. Vincent Medical Group

Indianapolis, Indiana 46260

United States

Kansas University Medical Center

Kansas City, Kansas 66160

United States

Abbott Northwestern

Minneapolis, Minnesota 55407

United States

Mayo Clinic

Rochester, Minnesota 55905

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Atrium Health

Charlotte, North Carolina 28203

United States

The Christ Hospital

Cincinnati, Ohio 45219

United States

The Ohio State University Medical Center

Columbus, Ohio 43210

United States

Oklahoma Heart Institute

Tulsa, Oklahoma 74104

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania 19096

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Swedish Medical Center

Seattle, Washington 98122

United States