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Not yet recruiting NCT07532369

Occlutech AFR Fontan Study

— Observational Failure of Fontan Type Circulation Fenestration Univentricular Heart Congenital Anomaly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Occlutech Atrial Flow Regulator Retrospective Data Collection.
Who it may be relevant to
Registry conditions: Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Device Occlutech Atrial Flow Regulator Retrospective Data Collection
    None, retrospective data collection only

Primary outcome measures

  • Primary Effectiveness Endpoint [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 7 centers
  • University of Alabama — Birmingham
  • Children's Hospital Los Angeles — Los Angeles
  • Rady Children's San Deigo — San Diego
  • Children's Hospital Colorado — Aurora
  • OSF Healthcare System d/b/a/ Saint Francis Medical Center — Peoria
  • Duke University — Durham
  • Cook Children's Health Care System — Fort Worth

Identifiers

NCT: NCT07532369 · OCC2025_04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗