Actively 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
Led by Kardium Inc. · Updated on 2025-06-16
115
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent symptomatic paroxysmal or persistent atrial fibrillation
- Failure or intolerance of at least one antiarrhythmic drug Class I or III
You will not qualify if you...
- Long-standing persistent atrial fibrillation lasting more than 12 months
- Atrial fibrillation caused by reversible or non-cardiac conditions
- History of thromboembolic events within the past six months
- Myocardial infarction or percutaneous coronary intervention within the last three months
- Any cardiac surgery in the previous six months
- Prior left atrial ablation or surgical procedure
- Presence of an implanted cardiac device
- Body mass index over 40 kg/m²
- Left ventricular ejection fraction below 35%
- Anterior-posterior left atrial diameter over 55 mm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, Germany, 67655
Actively Recruiting
Research Team
C
Clinical Affairs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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