Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04954911

Acronym

GLOBE-EU

Enrollment

Registered

2021-07-08

Start date

2021-11-02

Completion date

2023-05-23

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation, Radiofrequency RF Ablation, Globe Mapping and Ablation System

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Freedom from AF at 12 months following ablation with the Globe System	Up to 1 year
Freedom from AF/AFL/AT at 12 months following ablation with the Globe System	Up to 1 year
Device- and procedure-related adverse events within 12 months following ablation with the Globe System	Up to 1 year

Countries

Germany

Outcome results