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Occlutech AFR Fontan Study

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 15, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07532369
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
Related terms Congenital Abnormalities, Univentricular Heart
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov