ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.

Key facts

Study ID

NCT05686317

Run by

Edwards Lifesciences

People needed

100

Starts

2023-04-01

Expected to finish

2030-08-31

Last updated by the study team

2026-06-04

Who can join

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

Where it is running

• University of California Irvine — Irvine, California, United States
• University of California San Diego — La Jolla, California, United States
• Scripps Health — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• University of California San Francisco — San Francisco, California, United States
• Ascension Illinois Heart and Vascular Medical Group — Elk Grove, Illinois, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Francis Hospital & Heart Center — Roslyn, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• The Ohio State University — Columbus, Ohio, United States
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States
• Oregon Health and Science University — Oregon City, Oregon, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Medical University of South Carolina Charleston — Charleston, South Carolina, United States
• Instituto do Coracao da Universidade de Sao Paulo — São Paulo, Brazil
• The Ottawa Hospital — Ottawa, Canada, Canada
• Herz- und Diabeteszentrum NRW - Bad Oeynhausen — Bad Oeynhausen, Germany
• Herzzentrum Universitätsklinikum Köln — Cologne, Germany
• Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie — Dresden, Germany
• Universitätsklinikum Heidelberg Medizinische Klinik — Heidelberg, Germany
• Johannes Gutenberg Universitaet Mainz — Mainz, Germany
• Universitätsspital Basel — Basel, Switzerland

Full record on ClinicalTrials.gov

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