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Not yet recruiting NCT07651852

Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation

Observational Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Globe Pulsed Field System.
Who it may be relevant to
Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).

Interventions

  • Device Globe Pulsed Field System
    Ablation and atrial mapping with the Globe Pulsed Field System

Primary outcome measures

  • Effectiveness endpoint [Time frame: 12 months]
  • Safety endpoint [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • Patients with a planned ablation procedure using the commercially available Globe PF System

Exclusion criteria

  • Patients whose life expectancy is 1 year or less
  • Contraindication to left atrial catheter ablation or PF ablation
  • Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07651852 · DOC-321283

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗