New device offers hope for heart defect patients with failing circulation

NCT ID NCT07532369

Not yet recruiting Disease control Sponsor: Occlutech International AB Source: ClinicalTrials.gov ↗

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

Summary

This study looks at a device called the Occlutech Atrial Flow Regulator (AFR) in 25 people whose Fontan circulation (a surgery for a heart defect) is failing. The goal is to see if the device is safe and works well to create a small hole between heart chambers to improve blood flow. Participants have already received the device through a special FDA program.

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Conditions

The condition(s) this trial relates to.

Congenital Abnormalities univentricular heart

As listed by the trial registrant

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

CONGENITAL ANOMALY FAILURE OF FONTAN TYPE CIRCULATION FENESTRATION UNIVENTRICULAR HEART

Contacts and locations

Locations

Children's Hospital Colorado

Aurora, Colorado, 80045, United States
Children's Hospital Los Angeles

Los Angeles, California, 90027, United States
Cook Children's Health Care System

Fort Worth, Texas, 76104, United States
Duke University

Durham, North Carolina, 27705, United States
OSF Healthcare System d/b/a/ Saint Francis Medical Center

Peoria, Illinois, 61637, United States
Rady Children's San Deigo

San Diego, California, 92123, United States
University of Alabama

Birmingham, Alabama, 35233, United States

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