Post Market Registry of the CBSO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-05

Study Completion Date

2024-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Septal Defect Patent Foramen Ovale

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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ASD patients

Septal defect closure

Intervention Type DEVICE

Device closure of atrial septal defect

PFO patients

Septal defect closure

Intervention Type DEVICE

Device closure of atrial septal defect

Interventions

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Septal defect closure

Device closure of atrial septal defect

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No