Post Market Registry of the CBSO (CBSO Registry)

atHeart Medical

Status: Active, not recruiting

Conditions: Atrial Septal Defect; Patent Foramen Ovale

Treatments: Device: Septal defect closure

Study type: Observational

Funder types: Industry

Identifiers

NCT04105595

2019.8408

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

6 participants in 2 patient groups

ASD patients

Treatment:

Device: Septal defect closure

PFO patients

Treatment:

Device: Septal defect closure