Actively Recruiting
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Led by Kardium Inc. · Updated on 2026-01-30
175
Participants Needed
1
Research Sites
281 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
CONDITIONS
Official Title
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Planned for an atrial fibrillation catheter ablation procedure with documented history of atrial fibrillation
- Diagnosis of atrial fibrillation confirmed within 12 months before enrollment
- Had one previous pulmonary vein isolation procedure with cryoablation, radiofrequency ablation, or pulsed field ablation
- Between 18 and 75 years of age, inclusive
You will not qualify if you...
- Contraindications to open heart surgery
- Currently in an Intensive Care Unit
- Active systemic infection (sepsis)
- Previous ablation in the left or right atrium
- Post-heart transplant or awaiting cardiac transplantation or other cardiac surgery
- Cardiac implants interfering with device delivery or positioning (e.g., atrial septal defect closure device, left atrial appendage occluder)
- Mitral valve prolapse or other heart valve abnormalities except mild to moderate mitral regurgitation
- New York Heart Association Class III or IV heart failure
- History of thromboembolic event including stroke or transient ischemic attack
- History of bleeding disorders
- Known sensitivity to anesthesia or neuromuscular block agents
- Ongoing long-term treatment with steroids excluding intermittent inhaled steroids for respiratory disease
- Myocardial infarction within the last three months
- Atrioventricular block II° or III°
- Left ventricular ejection fraction less than 35%
- Unstable angina
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Motol and Homolka University Hospital
Prague, Czechia, 150 00
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
OTHER
Number of Arms
1
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