New heart device aims to ease pressure in failing hearts

NCT ID NCT03523416

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

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tests a device that creates a small opening between the upper chambers of the heart to relieve pressure in people with symptomatic heart failure. The study includes 71 participants and focuses on safety and whether the device works as intended. It is not a cure but aims to control the disease and improve symptoms.

What this could mean

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

Active substance: Transcatheter Atrial Shunt System (a device that creates a small passage between the upper chambers of the heart)
What this could lead to: If it works, this device could offer a new way to manage heart failure symptoms and reduce hospital stays.
What could go wrong: This is an early feasibility study with only 71 people, so it's too soon to know if it's safe or effective. There are risks of heart, brain, or kidney 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.

heart failure systolic heart failure

As listed by the trial registrant

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

HEART FAILURE

Contacts and locations

Locations

Abbott Northwestern

Minneapolis, Minnesota, 55407, United States
Atrium Health

Charlotte, North Carolina, 28203, United States
Kansas University Medical Center

Kansas City, Kansas, 66160, United States
Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
Medical University of South Carolina

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

The Bronx, New York, 10467, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
St. Vincent Medical Group

Indianapolis, Indiana, 46260, United States
Swedish Medical Center

Seattle, Washington, 98122, United States
The Christ Hospital

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

Columbus, Ohio, 43210, United States
UC San Diego Health

La Jolla, California, 92037, United States
University California San Francisco

San Francisco, California, 94143, United States
University of Florida Health - Jacksonville

Jacksonville, Florida, 32209, United States

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