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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum NRW, Bad Oeynhausen, North Rhine-Westphalia, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Freedom from AF at 12 months following ablation with the Globe System

Time frame: Up to 1 year
Freedom from AF/AFL/AT at 12 months following ablation with the Globe System

Time frame: Up to 1 year
Device- and procedure-related adverse events within 12 months following ablation with the Globe System

Time frame: Up to 1 year

Sponsors and collaborators

Lead sponsor

Kardium Inc.

Industry

Registry information

Official study title

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

Acronym: GLOBE-EU

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jul 8, 2021
Registry last updated: Sep 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed