Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Ablation System using Pulsed Field Ablation (PFA) for treating subjects with atrial fibrillation (AF).

Official Title
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PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Globe Mapping and Ablation System (Globe System)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects planned for an AF catheter ablation procedure, with a documented history of AF. Diagnosis must be confirmed within 12 months before enrollment. Subjects between 18 and 75 years of age, inclusive Exclusion Criteria: Patients who have contraindications to open heart surgery Patients from an Intensive Care Unit Patients with active systemic infection (sepsis) Patients requiring concomitant right atrial ablation (as determined before the procedure) Patients who have had previous ablation in the left atrium Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder) Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation Patients with New York Heart Association Class III or IV heart failure History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA) Bleeding disorder history Patients with a known sensitivity to anesthesia or neuromuscular block agent Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease Myocardial infarction within the last three months Atrioventricular (AV) block II° or III° Atrial flutter Left ventricular ejection fraction (LVEF) of less than 35% Unstable angina

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Globe Mapping and Ablation System<br> | Device: Globe Mapping and Ablation System (Globe System)<br>* During the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by PFA to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe System will be used to confirm PVI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of subjects presenting with primary safety events which are device- or procedure-related |  | up to 3-month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Globe Mapping and Ablation System, Atrial Fibrillation, Pulsed Field Ablation