Post Market Registry of the CBSO
Active, not recruiting
- Conditions
- Patent Foramen OvaleAtrial Septal Defect
- Interventions
- Device: Septal defect closure
- Registration Number
- NCT04105595
- Lead Sponsor
- atHeart Medical
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 6
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PFO patients Septal defect closure - ASD patients Septal defect closure -
- Primary Outcome Measures
Name Time Method Effective closure by echocardiography at 6 months Safety throughout the follow up duration by absence of serious incidents day 0 to 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany