Failure of Fontan Type CirculationNCT07532369
Occlutech AFR Fontan Study
An observational study of Failure of Fontan Type Circulation and Fenestration, run by Occlutech International AB at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart
- What is being tested?
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 May 2026to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
Emily Bowhay, M.S., 720-777-7292, Emily.Bowhay@childrenscolorado.org
Gareth Morgan, M.D.
University of Alabama
Birmingham, Alabama, 35233
Kristal Hock, kristalhock@uabmc.edu
Mark Law, M.D.
Duke University
Durham, North Carolina, 27705
Melissa Harward, MSCR, 919-668-3910, melissa.harward@duke.edu
Gregory Fleming, M.D.
Cook Children's Health Care System
Fort Worth, Texas, 76104
Samantha Soloman, M.S., 682-303-3249, raostartup@cookchildrens.org
Dennis Vanloozen, M.D.
Children's Hospital Los Angeles
Los Angeles, California, 90027
Sydney Rosan, BA, 353-361-5829, srosen@chla.usc.edu
Neil Patel, M.D.
OSF Healthcare System d/b/a/ Saint Francis Medical Center
Peoria, Illinois, 61637
Ashley Edelen, MSCR, 309-624-2507, aedelen@uic.edu
Priti Patel, M.D.
Rady Children's San Deigo
San Diego, California, 92123
Edgar Alfaro, M.D., MPH, 858-576-1700 ext. 223468, ealfaro@rchsd.org
Brent Gordon, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Being tested
- Occlutech Atrial Flow Regulator Retrospective Data Collection
- Medical subject headings
- Univentricular Heart, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlutech Atrial Flow Regulator Retrospective Data CollectionDevice
None, retrospective data collection only
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Endpoint
Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure of Fontan Type CirculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532369
- Sponsor's protocol ID
- OCC2025_04
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Experience With the Occlutech Atrial Flow Regulator (Occlutech AFR) in a Failing Fontan Population
- ClinicalTrials.gov ID
- NCT07532369
- Acronym / sponsor ID
- OCC2025_04
- Conditions
- Failure of Fontan Type Circulation, Fenestration, Univentricular Heart, Congenital Anomaly
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 1 May 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- If a subject does not meet the eligibility criteria, they will be considered a Screen Failure and cannot be included
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlutech Atrial Flow Regulator Retrospective Data CollectionNone, retrospective data collection only | Device | – |
Primary outcome
Primary Effectiveness Endpoint
Time frame: 1 year
Shunt patency defined by persistent right to left shunt assessed by echocardiography at 1-year post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failure of Fontan Type Circulation and Fenestration, run by Occlutech International AB at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ramona Ruble (1-612-644-9990, ramona.ruble@occlutech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Endpoint (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.