Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population
Occlutech International AB
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.
Description
The Occlutech AFR Fontan Study is a single arm, observational, multicenter clinical investigation of the Occlutech Atrial Flow Regulator investigational device. This is a retrospective, non-interventional, observational study that utilizes existing clinical data previously collected during standard patient care. No new procedures or treatments will be administered as part of this study. This study will comprise a case series of congenital patients with Fontan failure who have been treated with an Occlutech AFR. The scope of this study is to gain clinical experience on the Occlutech AFR in Fo…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included
Interventions
- DeviceOcclutech Atrial Flow Regulator Retrospective Data Collection
None, retrospective data collection only
Locations (7)
- University of AlabamaBirmingham, Alabama
- Children's Hospital Los AngelesLos Angeles, California
- Rady Children's San DeigoSan Diego, California
- Children's Hospital ColoradoAurora, Colorado
- OSF Healthcare System d/b/a/ Saint Francis Medical CenterPeoria, Illinois
- Duke UniversityDurham, North Carolina