Trials / Active Not Recruiting
Active Not RecruitingNCT05462145
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 549 (estimated)
- Sponsor
- Kardium Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Globe Pulsed Field System | Ablation and atrial mapping with the Globe Pulsed Field System |
Timeline
- Start date
- 2023-03-09
- Primary completion
- 2026-09-01
- Completion
- 2026-09-01
- First posted
- 2022-07-18
- Last updated
- 2026-01-30
Locations
18 sites across 4 countries: United States, Canada, Czechia, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05462145. Inclusion in this directory is not an endorsement.