NCT07532369Not yet recruiting
Occlutech AFR Fontan Study
Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Occlutech International AB
- NCT number
- NCT07532369
What you commit to
- Study type: Observational
- Planned participants: 25
- From 1 May 2026 to the primary completion date, 31 Aug 2026
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Alabama Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Cook Children's Health Care System Coordinator of this site? Confirm its status | Fort Worth | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| OSF Healthcare System d/b/a/ Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Rady Children's San Deigo Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.