Heart shunt shows promise for easing heart failure symptoms

NCT ID NCT05686317

Ongoing Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called the Edwards APTURE shunt, which is implanted in the heart to create a small opening that lowers pressure. The goal is to see if it can improve symptoms and quality of life for 100 people with a certain type of heart failure. Half of the participants get the real shunt, and half get a sham procedure, so the results will be compared fairly.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Edwards APTURE transcatheter shunt system (a device implanted to create a small passage between heart chambers to reduce pressure)
What this could lead to: If it works, this could offer a new device-based option to improve symptoms and quality of life for people with heart failure who have limited treatment choices.
What could go wrong: This is a relatively small, early-stage trial (100 people) and the device is compared to a sham procedure, so results may not be definitive. There are also risks from the implant procedure, such as serious heart or blood vessel complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HEART FAILURE

Contacts and locations

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Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Ascension Illinois Heart and Vascular Medical Group

Elk Grove, Illinois, 60007, United States
Herz- und Diabeteszentrum NRW - Bad Oeynhausen

Bad Oeynhausen, 32545, Germany
Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie

Dresden, 01307, Germany
Herzzentrum Universitätsklinikum Köln

Cologne, 50937, Germany
Instituto do Coracao da Universidade de Sao Paulo

São Paulo, 05403-900, Brazil
Johannes Gutenberg Universitaet Mainz

Mainz, 55131, Germany
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States
Mayo Clinic

Rochester, Minnesota, 55902, United States
Medical University of South Carolina Charleston

Charleston, South Carolina, 29425', United States
Montefiore Medical Center

The Bronx, New York, 10467, United States
Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States
Oregon Health and Science University

Oregon City, Oregon, 97239, United States
Scripps Health

La Jolla, California, 92037, United States
St. Francis Hospital & Heart Center

Roslyn, New York, 11576, United States
The Christ Hospital

Cincinnati, Ohio, 45219, United States
The Ohio State University

Columbus, Ohio, 43210, United States
The Ottawa Hospital

Ottawa, Canada, Canada
University of California Irvine

Irvine, California, 92868, United States
University of California San Diego

La Jolla, California, 92027, United States
University of California San Francisco

San Francisco, California, 94143, United States
University of Southern California

Los Angeles, California, 90033, United States
Universitätsklinikum Heidelberg Medizinische Klinik

Heidelberg, 69120, Germany
Universitätsspital Basel

Basel, 4031, Switzerland

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