Atrial Fibrillation
Conditions
Brief summary
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
Ablation and atrial mapping with the Globe Pulsed Field System
Sponsors
Study design
Eligibility
Inclusion criteria
Key Inclusion Criteria: * Patients with a planned ablation procedure using the commercially available Globe PF System Key
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness endpoint | 12 months | Rate of 12-month treatment success following ablation using the Globe PF System. |
| Safety endpoint | 7 days | Rate of subjects with one or more major adverse events up to 7 days following the index ablation procedure. |