A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 25
- 主要终点
- AtriCure commercially available devices used to treat IST or POTS
研究概览
简要总结
The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.
- •Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements
排除标准
- •Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
- •Subject with exclusion criteria required by FDA or local governance
结局指标
主要结局
AtriCure commercially available devices used to treat IST or POTS
时间窗: 12 months
The IST Registry will attempt to enroll all eligible patients at registry sites who have already had or are scheduled to have a procedure to treat IST/POTS that includes the use of at least one commercially available AtriCure cardiac ablation devices.
AtriCure commercially available devices used to treat IST or POTS
时间窗: 5 years
The IST Registry will attempt to enroll all eligible patients at registry sites who have already had or are scheduled to have a procedure to treat IST/POTS that includes the use of at least one commercially available AtriCure cardiac ablation devices.
次要结局
未报告次要终点