Status:
UNKNOWN
Post Market Registry of the CBSO
Lead Sponsor:
atHeart Medical
Conditions:
Atrial Septal Defect
Patent Foramen Ovale
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04105595
Start Date
March 5 2020
End Date
October 1 2024
Last Update
July 21 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Deutsches Herzzentrum Berlin
Berlin, Germany