Galvanize Prospective/Retrospective Pulsed Electric Field Device Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 11
- 主要终点
- PEF Target Size
研究概览
简要总结
The goal of this observational registry is to assess the use and performance of Galvanize PEF technology in a real-world setting. The main questions it aims to answer are:
- PEF utilization and performance
- Monitor safety outcomes and inform future generation devices.
Participants will undergo the PEF procedure and be followed per institutional standard of care.
详细描述
This is a multi-center, observational registry that follows patients for a total of 2 years from the date of the Pulsed Electric Field (PEF) procedure with the FDA cleared Galvanize Technology.
Patients will be enrolled and followed prospectively or enrolled retrospectively with prospective, longitudinal follow up.
Enrollment for this study will include up to 200 patients throughout the US who underwent or are scheduled to undergo PEF energy delivery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject will undergo or has undergone PEF energy delivery utilizing Galvanize technology
- •Subject is expected to be available for follow-up per the enrolling physician's standard care practices
- •For prospective cohort, subject has a life expectancy of at least 3 months; for retrospective cohort, subject has completed at least three months of imaging following the PEF procedure
- •Signed informed consent is obtained, if required by IRB
排除标准
- 未提供
研究组 & 干预措施
Aliya PEF ablation
Patients will undergo PEF ablation per institutional standard of care
干预措施: PEF ablation (Device)
结局指标
主要结局
PEF Target Size
时间窗: PEF procedure
PEF target size (cm)
Anesthesia Type Usage for PEF Procedure
时间窗: PEF procedure
Anesthesia type usage
PEF Target Location
时间窗: PEF procedure
PEF procedural target location
次要结局
- Incidence of SAEs(within 30 days of PEF energy delivery)
- Unanticipated [not listed in the Instructions for Use (IFU)] adverse events(within 30 days of PEF energy delivery)