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

atHeart Medical1 site in 1 country6 target enrollmentMarch 5, 2020

ConditionsAtrial Septal Defect Patent Foramen Ovale

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Septal Defect
Sponsor: atHeart Medical
Enrollment: 6
Locations: 1
Primary Endpoint: Effective closure by echocardiography
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 5, 2020

End Date

October 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

atHeart Medical

Responsible Party

Sponsor

Eligibility Criteria

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.