Occlutech AFR Fontan Study
NCT: NCT07532369 · NOT_YET_RECRUITING
Brief Summary
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.
Frequently Asked Questions
What is Occlutech AFR Fontan Study?
Occlutech AFR Fontan Study is a clinical trial registered under NCT07532369. Current status: NOT_YET_RECRUITING.
What is the status of NCT07532369?
The current status of NCT07532369 (Occlutech AFR Fontan Study) is: NOT_YET_RECRUITING.
When did Occlutech AFR Fontan Study start?
Occlutech AFR Fontan Study started on 2026-05-01.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.