Atrial Septal Defect, Patent Foramen Ovale
Conditions
Brief summary
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use
Interventions
DEVICESeptal defect closure
Device closure of atrial septal defect
Sponsors
atHeart Medical
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO. * Patient (or legal guardian) has been informed and agreed to and signed the informed consent form. * A CBSO is implanted into the patient.
Exclusion criteria
* Patient is known to have one or more of the contraindications listed in the instructions for use. * Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO. * Patient is implanted with another product in the atrial septum.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective closure by echocardiography | at 6 months |
| Safety throughout the follow up duration by absence of serious incidents | day 0 to 3 years |
Countries
Germany
Outcome results
None listed