Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- VERAFEYE Performance
研究概览
简要总结
The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).
Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 standard of care 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: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)
- •EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure
- •EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure
- •EC6: Life expectancy less than 12 months
- •EC7: 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.
- •EC8: Subjects who are currently enrolled in another study
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 Imaging and Guidance System (Device)
结局指标
主要结局
VERAFEYE Performance
时间窗: during procedure
• Ability of VERAFEYE Imaging and Guidance System to: * Visualize major cardiac structures (e.g. RA, septum, LA, PVs) * Create 3D anatomical model with the VERAFEYE Imaging and Guidance System
ADEs
时间窗: within 7 days of the index procedure
• Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure
VERAFEYE Performance
时间窗: during procedure
• Ability of VERAFEYE Imaging and Guidance System to: * Visualize major cardiac structures (e.g. RA, septum, LA, PVs) * Create 3D anatomical model with the VERAFEYE Imaging and Guidance System
次要结局
未报告次要终点