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

Kardium Inc.1 个研究点分布在 1 个国家目标入组 175 人2021年12月8日

适应症Atrial Fibrillation

干预措施Globe Mapping and Pulsed Field Ablation System (Globe PF System)

概览

阶段: 不适用
干预措施: Globe Mapping and Pulsed Field Ablation System (Globe PF System)
疾病 / 适应症: Atrial Fibrillation
发起方: Kardium Inc.
入组人数: 175
试验地点: 1
主要终点: Rate of subjects presenting with primary safety events which are device- or procedure-related
状态: 招募中
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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).

注册库

clinicaltrials.gov

开始日期

2021年12月8日

结束日期

2027年5月1日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Kardium Inc.

责任方

Sponsor

入排标准

入选标准

•Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
•Diagnosis must be confirmed within 12 months before enrollment.
•(Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
•Subjects between 18 and 75 years of age, inclusive

排除标准

•Patients who have contraindications to open heart surgery
•Patients from an Intensive Care Unit
•Patients with active systemic infection (sepsis)
•Patients who have had previous ablation in the left or right 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