Trials / Recruiting
RecruitingNCT06973031
A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- Sponsor
- Kardium Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Globe Pulsed Field System | Ablation and atrial mapping with the Globe Pulsed Field System |
Timeline
- Start date
- 2025-06-10
- Primary completion
- 2028-06-01
- Completion
- 2028-06-01
- First posted
- 2025-05-15
- Last updated
- 2025-06-16
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT06973031. Inclusion in this directory is not an endorsement.