Status:
RECRUITING
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
Lead Sponsor:
Kardium Inc.
Conditions:
Paroxysmal Atrial Fibrillation (PAF)
Persistent Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Eligibility Criteria
Key inclusion criteria:
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Key exclusion criteria:
- Long-standing persistent AF (sustained >12 months)
- Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
- History of thromboembolic events within the past six months
- Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
- Any cardiac surgery within the previous six months
- Prior left atrial ablation or surgical procedure
- Presence of an implanted cardiac device
- Body mass index (BMI) >40 kg/m^2
- Left ventricular ejection fraction (LVEF) <35%
- Anterior-posterior left atrial (LA) diameter >55mm
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT06973031
Start Date
June 10 2025
End Date
June 1 2028
Last Update
June 16 2025
Active Locations (1)
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1
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany, 67655