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NCT04105595 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design

Related Conditions & MeSH terms

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
See also
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Active, not recruiting NCT04738071 - International Multicenter Patent foRamen OVale & strokE (IMPROVE) Registry
Not yet recruiting NCT06413147 - Long-term Procedural and Device Related Complications of PFO Closure
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