An observational study in Failure of Fontan Type Circulation, Fenestration and Univentricular Heart, sponsored by Occlutech International AB. Not yet recruiting at 7 sites in United States. Per ClinicalTrials.gov, last updated 2026-04-15.
Sponsored by Occlutech International AB · Observational
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.
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 Fontan failure patients. Cases in this study will be assessed to evaluate the safety and effectiveness of the device in a real-life scenario.
Sites will be selected in the U.S. that had previously attempted expanded access cases with the Occlutech AFR for Fontan failure. Data will be collected retrospectively up to a site-specific cut-off date, which will be either the date of IRB submission or IRB approval, per site IRB policy. The requirement for informed consent and HIPAA authorization will be determined by each IRB in accordance with applicable policies; waivers may be obtained where permissible. It is anticipated that 7 sites will be initiated for the study, and data from approximately 25 patients will be included.
Data will be descriptively compared to those available in the literature describing interventions on Fontan to modulate fenestration size.
86 studies on the registry are indexed under Univentricular Heart; 22 are open to participants now.
This study's planned enrollment of 25 is below the median of 42 across 37 observational studies indexed under Univentricular Heart.
Browse Univentricular Heart studies →Occlutech International AB is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will include participants with a dysfunctional Fontan circulation who can benefit from the creation, enlargement, or reduction of a fenestration to achieve tolerable systemic venous pressures.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
None, retrospective data collection only
Primary Effectiveness Endpoint
Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.
Time frame: 1 year
Primary Safety Assessment
The primary safety assessment is serious device or procedure related adverse events (SADEs), including peri-procedural SAEs assessed through 30 days post-procedure.
Time frame: 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Occlutech International AB