Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation (GLOBE-EU)

Kardium

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT04954911

DOC-138528

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Contraindication for catheter ablation with the Globe System
2. Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
3. 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.