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

Edwards Lifesciences

Summary

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

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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. Pa…

Interventions

Device
Edwards APTURE transcatheter shunt system
Transcatheter treatment of symptomatic heart failure patients with elevated left atrial pressure.

Locations (19)

UC San Diego Health
La Jolla, California
Cedars Sinai Medical Center
Los Angeles, California
University California San Francisco
San Francisco, California
University of Colorado
Aurora, Colorado
University of Florida Health - Jacksonville
Jacksonville, Florida
St. Vincent Medical Group
Indianapolis, Indiana