Occlutech AFR Fontan Study

Starting soon

Conditions studied: Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly

In brief

The goal of this observational clinical study look at the safety and effectiveness of the Occlutech Atrial Flow Regulator in the treatment of patients with failing Fontan circulation. This study will consist of a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR under the FDA's Expanded Access process. The scope of this study is to gain clinical experience on the Occlutech AFR in Fontan failure patients. Cases in this study will be evaluated to evaluate the safety and effectiveness of the device. The objective of this study is to evaluate the Occlutech AFR with respect to device safety and shunt patency at 1 year. Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.

Key facts

Study ID

NCT07532369

Run by

Occlutech International AB

People needed

25

Starts

2026-05-01

Expected to finish

2026-09-01

Last updated by the study team

2026-04-15

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has been treated with an AFR device (attempted or successful) for failing Fontan through the Expanded Access Program of the Food and Drug Administration (FDA).
• The candidate/candidate's legal guardian has been informed of the nature of the study, agrees to its provisions and has provided written informed consent unless the site's IRB provided a waiver of consent.

You may not qualify if…

• If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Rady Children's San Deigo — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• OSF Healthcare System d/b/a/ Saint Francis Medical Center — Peoria, Illinois, United States
• Duke University — Durham, North Carolina, United States
• Cook Children's Health Care System — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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