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CompletedNCT04954911GLOBE-EUUpdated Sep 18, 2023

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

An observational study in Atrial Fibrillation, sponsored by Kardium Inc.. Completed at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Kardium Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Atrial Fibrillation
  • Radiofrequency RF Ablation
  • Globe Mapping and Ablation System
03

In context

Atrial Fibrillation

3,872 studies on the registry are indexed under Atrial Fibrillation; 926 are open to participants now.

This study's enrollment of 6 is below the median of 300 across 1,364 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Kardium Inc. is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

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

    Time frame: Up to 1 year

  2. Freedom from AF/AFL/AT at 12 months following ablation with the Globe System

    Time frame: Up to 1 year

  3. Device- and procedure-related adverse events within 12 months following ablation with the Globe System

    Time frame: Up to 1 year

07

Study locations

2 sites
  • Herz- und Diabeteszentrum NRW
    Bad Oeynhausen, North Rhine-Westphalia 32545, Germany
  • Herzzentrum Leipzig
    Leipzig, Saxony 04289, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04954911
Lead sponsor
Kardium Inc.
Responsible party
Sponsor
First posted
Jul 8, 2021
Start date
Nov 2, 2021
Primary completion
May 23, 2023
Completion
May 23, 2023
Last update
Sep 18, 2023

Study contacts

Herz- und Diabeteszentrum NRW
principal investigator · Klinik für Elektrophysiologie/Rhythmologie Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Kardium Inc.

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