Prospective, Multi-centre, Observational Registry to Evaluate the Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation

Kardium Inc.2 sites in 1 country6 target enrollmentNovember 2, 2021

ConditionsAtrial Fibrillation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Kardium Inc.
Enrollment: 6
Locations: 2
Primary Endpoint: Freedom from AF at 12 months following ablation with the Globe System
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an observational, multicentre, prospective, post-market product registry for participants with AF for whom ablation by the commercially available Globe Mapping and Ablation System was indicated before enrolment into the registry. The aim of the registry is to confirm the clinical performance and safety of the Globe Mapping and Ablation System in a real-life setting.

Registry

clinicaltrials.gov

Start Date

November 2, 2021

End Date

May 23, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Kardium Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 years or older
•Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry
•Signed informed consent

Exclusion Criteria

•Contraindication for catheter ablation with the Globe System
•Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
•Physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.