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Occlutech AFR Fontan Study

Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the safety and effectiveness of the Occlutech Atrial Flow Regulator (AFR) device in people whose Fontan circulation is failing. Fontan circulation is blood flow created by surgery for a heart defect present at birth. The study follows people already treated with the device and checks after 1 year whether the opening still lets blood flow from right to left.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You had an attempted or successful AFR device treatment for failing Fontan circulation through the FDA's Expanded Access Program.
  • You or your legal guardian were told about the study, agreed to its rules, and gave written consent, unless the study site's review board waived the need for consent.

Who can't join

  • You cannot join if you do not meet the study's entry rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (7)

AL

CA

CO

IL

NC

TX