Occlutech AFR Fontan Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOcclutech International AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Occlutech Atrial Flow Regulator Retrospective Data Collection
DeviceNone, retrospective data collection only
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Effectiveness Endpoint
Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.
Time frame
1 yearOther outcomes
1
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 daysSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: