Luma Vision's Feasibility Study on the VERAFEYE System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Physician Feedback on VERAFEYE System
研究概览
简要总结
The objective of the study is to evaluate the performance of the VERAFEYE System in subjects entitled to undergo a standard of care ablation or closure procedure.
Results from this study will be used to guide development and refinement the VERAFEYE System. The study is not designed to collect data for product approval and as such does not have a safety or efficacy endpoint.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 to 80 years of age at the time of consent
- •Subject is scheduled to undergo a standard of care, de-novo catheter-ablation procedure to treat typical AFL or AF; or left atrial appendage (LAA)/ atrial septal defect (ASD) closure procedure
- •Subject is able to understand and willing to provide written informed consent
排除标准
- •Any of the following within 6 months prior to enrolment:
- •Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
- •Thromboembolic event (stroke), transient ischemic attack (TIA) or neurological disturbances
- •Myocardial infarction
- •Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
- •Dilated or hypertropic cardiomyopathy
- •Any planned surgical or endovascular intervention within 30 days before or after the ablation, or LAA/ASD closure procedure.
- •Any of the following cardiac conditions:
- •New York Heart Association (NYHA) class IV
- •Left ventricular ejection fraction (LVEF) < 30%
- •Implanted with a cardiac rhythm management device (pacemaker, CRT, ICD, loop recorder)
- •Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
- •Active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
- •Body mass index (BMI) > 40 kg/m2
- •Body weight < 50kg
- •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 ablation, or LAA/ASD closure procedure)
- •Life expectancy less than 12 months
- •Subjects who are currently enrolled in another study
- •Subjects with a thrombus or pericardial effusion detected in the LA/LAA during standard of care imaging
研究组 & 干预措施
Catheter-ablation and closure procedures arm
Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation and subjects entitled to undergo a left atrial appendage/atrial septal defect closure procedure
干预措施: VERAFEYE System (Device)
结局指标
主要结局
Physician Feedback on VERAFEYE System
时间窗: During the procedure (up to two hours)
The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System.
次要结局
未报告次要终点