Post Market Registry of the CBSO

Patent Foramen Ovale Clinical Trial

— CBSO Registry  

Official title:

Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04105595
• Other study ID #: 2019.8408
• Status: Active, not recruiting
• Start date: March 5, 2020
• Est. completion date: October 2024

Study information

• Verified date: July 2022
• Source: atHeart Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Septal Defect
• Foramen Ovale, Patent
• Heart Septal Defects, Atrial
• Patent Foramen Ovale

Intervention

Device:
• Septal defect closure
Device closure of atrial septal defect

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
atHeart Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective closure by echocardiography		at 6 months
Primary	Safety throughout the follow up duration by absence of serious incidents		day 0 to 3 years