Not yet recruiting NCT07651852
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic 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 →
Unsure about the terms? Read our patient guide →
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