Occlutech AFR Fontan Study

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Occlutech International AB
Study ID
NCT07532369
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
25 participants (estimated)

Primary Outcome Measure

Primary Effectiveness Endpoint [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35233
Kristal Hock
[email protected]
Mark Law, M.D. (PRINCIPAL_INVESTIGATOR)
Children's Hospital Los AngelesLos AngelesCalifornia90027
Sydney Rosan, BA
[email protected]
353-361-5829
Neil Patel, M.D. (PRINCIPAL_INVESTIGATOR)
Darren Berman, M.D. (SUB_INVESTIGATOR)
Rady Children's San DeigoSan DiegoCalifornia92123
Edgar Alfaro, M.D., MPH
[email protected]
858-576-1700
Brent Gordon, M.D. (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Emily Bowhay, M.S.
[email protected]
720-777-7292
Gareth Morgan, M.D. (PRINCIPAL_INVESTIGATOR)
Jenny Zablah, M.D. (SUB_INVESTIGATOR)
OSF Healthcare System d/b/a/ Saint Francis Medical CenterPeoriaIllinois61637
Ashley Edelen, MSCR
[email protected]
309-624-2507
Priti Patel, M.D. (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Melissa Harward, MSCR
[email protected]
919-668-3910
Gregory Fleming, M.D. (PRINCIPAL_INVESTIGATOR)
Amanda Picart, M.D. (SUB_INVESTIGATOR)
Reid Chamberlain, M.D. (SUB_INVESTIGATOR)
Cook Children's Health Care SystemFort WorthTexas76104
Samantha Soloman, M.S.
[email protected]
682-303-3249
Dennis Vanloozen, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama· Birmingham, ALChildren's Hospital Los Angeles· Los Angeles, CARady Children's San Deigo· San Diego, CAChildren's Hospital Colorado· Aurora, COOSF Healthcare System d/b/a/ Saint Francis Medical Center· Peoria, ILDuke University· Durham, NC

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