Occlutech AFR Fontan Study

NCT07532369 | Not Yet Recruiting FDA Device

• 1 other identifier: OCC2025_04
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Failure of Fontan Type Circulation; Fenestration; Univentricular Heart; Congenital Anomaly

Outcome Measures

Primary Outcomes (1)

• Primary Effectiveness Endpoint

  Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.

  1 year

Other Outcomes (1)

• Primary Safety Assessment

  30 days

Interventions

Occlutech Atrial Flow Regulator Retrospective Data Collection DEVICE

None, retrospective data collection only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (7)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Rady Children's San Deigo

San Diego, California, 92123, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

OSF Healthcare System d/b/a/ Saint Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Cook Children's Health Care System

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Univentricular Heart; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ramona Ruble

CONTACT

1-612-644-9990; ramona.ruble@occlutech.com

Diana Ekholm

CONTACT

1-805-338-3543; diana.shycoff@occlutech.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)