Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

Running, not enrolling · Not applicable

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT03523416

Run by

Edwards Lifesciences

People needed

71

Starts

2018-07-31

Expected to finish

2028-11-01

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC San Diego Health — La Jolla, California, United States
• University California San Francisco — San Francisco, California, United States
• University of Florida Health - Jacksonville — Jacksonville, Florida, United States
• St. Vincent Medical Group — Indianapolis, Indiana, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Abbott Northwestern — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Atrium Health — Charlotte, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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