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

Atrial Fibrillation Clinical Trial

— GLOBE-EU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04954911
• Other study ID #: DOC-138528
• Status: Completed
• Start date: November 2, 2021
• Est. completion date: May 23, 2023

Study information

• Verified date: September 2023
• Source: Kardium Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 23, 2023
• Est. primary completion date: May 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	North Rhine-Westphalia
Germany	Herzzentrum Leipzig	Leipzig	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Kardium Inc.

Country where clinical trial is conducted

Germany, 

Outcome

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