Clinical Research Trials using the CardioSEAL and STARFlex devices:
The CardioSEAL device has been approved under
Humanitarian Use Guidelines by the FDA for the closure of Fontan fenestrations
(FenFon), Ventricular Septal Defects (VSD), and Patent Foramen Ovale
(PFO). Patients with other types of heart defects will need to be enrolled
in one of the ongoing clinical research trials. The STARFlex device is
available through clinical research trials only.
Below is information regarding the different types of trials that are currently
using the CardioSEAL and STARFlex devices. Patients are enrolled in the
studies based on their diagnosis and current health, and are usually referred by
- ASD Trial - for patients with single
heart defects & no other medical condition(s).
- High Risk Trial - for patients
with more complicated medical condition(s).
- PFO Trial - for patients with
uncomplicated PFO defects. In this trial, patients will be
randomly selected to receive either the STARFlex device or to take blood
- Device Patient Registry - for
patients who have completed the required follow-up period, a registry has
been developed. For patients who agree to participate, this will
allow us to follow them long term.