Occlutech AFR Fontan Study

April 8, 2026 updated by: Occlutech International AB

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 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.

Study Type

Observational

Enrollment (Estimated)

25

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
        • Contact:
        • Principal Investigator:
          • Mark Law, M.D.
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
        • Contact:
        • Principal Investigator:
          • Neil Patel, M.D.
        • Sub-Investigator:
          • Darren Berman, M.D.
      • San Diego, California, United States, 92123
        • Rady Children's San Deigo
        • Contact:
        • Principal Investigator:
          • Brent Gordon, M.D.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
        • Contact:
        • Principal Investigator:
          • Gareth Morgan, M.D.
        • Sub-Investigator:
          • Jenny Zablah, M.D.
    • Illinois
      • Peoria, Illinois, United States, 61637
        • OSF Healthcare System d/b/a/ Saint Francis Medical Center
        • Contact:
        • Principal Investigator:
          • Priti Patel, M.D.
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
        • Contact:
        • Principal Investigator:
          • Gregory Fleming, M.D.
        • Sub-Investigator:
          • Amanda Picart, M.D.
        • Sub-Investigator:
          • Reid Chamberlain, M.D.
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Health Care System
        • Contact:
        • Principal Investigator:
          • Dennis Vanloozen, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Endpoint
Time Frame: 1 year
Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Assessment
Time Frame: 30 days
The primary safety assessment is serious device or procedure related adverse events (SADEs), including peri-procedural SAEs assessed through 30 days post-procedure.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCC2025_04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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