Post Market Registry of the CBSO

Active, not recruiting

• Conditions: Patent Foramen Ovale; Atrial Septal Defect

• 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

Study Timeline

• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-26
• Study Start: 2020-03-05
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-21
• Primary Completion: 2023-10
• Study Completion: 2024-10

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

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

Trial Locations

Locations (1)

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany