Post Market Registry of the CBSO

atHeart Medical6 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Atrial Septal Defect Patent Foramen Ovale

Interventions

Septal defect closureDEVICE

Device closure of atrial septal defect

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Deutsches Herzzentrum Berlin

Berlin, Germany

Outcomes

Primary Outcomes

Effective closure by echocardiography

Time frame: at 6 months

Safety throughout the follow up duration by absence of serious incidents

Time frame: day 0 to 3 years

Data from ClinicalTrials.gov

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