Anatomical Navigation for Guided Electrophysiology in AFL and AFib
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Acute procedural success rates during the index procedure
研究概览
简要总结
The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).
The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IC1: Subject is at least 18 years of age at the time of consent
- •IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (*according to current international and local guidelines and per physician discretion)
- •IC3: Subject is able to understand and willing to provide written informed consent
- •IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site
排除标准
- •EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion
- •EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)
- •EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- •EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.
- •EC5: Life expectancy less than 12 months
- •EC6: Current LA thrombus
- •Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.
研究组 & 干预措施
Atrial Fibrillation and Atrial Flutter arm
Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation
干预措施: VERAFEYE Anatomic Guidance System (Device)
结局指标
主要结局
Acute procedural success rates during the index procedure
时间窗: During the procedure
A procedure will be defined as successful if all the following conditions occur during the case: * Ability to create a 3D anatomical model of RA and/or LA with the VERAFEYE Imaging and Guidance System and * Ability to complete all necessary ablation lesion sets using the 3D anatomical model of RA and/or LA created with the VERAFEYE System
次要结局
未报告次要终点