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Clinical Trials in the USA / NCT03523416
Active, not recruiting Not applicable

Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

NCT03523416 · tracked via the Priya Life Science USA tracker
Sponsor
Edwards Lifesciences
Phase
Not applicable
Started
2018-07-31
Last updated
2025-09-19

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Transcatheter Atrial Shunt System

Transcatheter Atrial Shunt System: Transcatheter treatment of symptomatic left heart failure patients

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (15)

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

More Edwards Lifesciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03523416 on ClinicalTrials.gov ↗ ← All trials in the USA