Post Market Registry of the CBSO | NCT04105595

Studies
Post Market Registry of the CBSO

NCT04105595

Sponsor

atHeart Medical

Status

Unknown status

Last Update Posted

Jul 21, 2022Actual

Enrollment

6Actual

Phase

Not provided

Conditions

Atrial Septal Defect
Patent Foramen Ovale

Interventions

Septal defect closure

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2020Actual

Primary Completion Date

Oct 2023Estimated

Completion Date

Oct 2024Estimated

First Submitted Date

Sep 24, 2019

First Submission Date that Met QC Criteria

Sep 25, 2019

First Posted Date

Sep 26, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2022

Last Update Posted Date

Jul 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ASD patients			Device: Septal defect closure
PFO patients			Device: Septal defect closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Septal defect closure	Device	Device closure of atrial septal defect	ASD patients PFO patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Intent to treat population: All enrolled patients Modified Intent to Treat population: All enrolled patients who have a permanently implanted CBSO.

Per Protocol population: All patients in the enrolled population who have a permanently implanted CBSO and do not have a major protocol deviation. The per protocol population will be used as the final population for analysis.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D006344	Heart Septal Defects, Atrial
D054092	Foramen Ovale, Patent

Ancestor Terms

ID	Term
D006343	Heart Septal Defects
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided