DiamondTemp Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 545
- 试验地点
- 32
- 主要终点
- Freedom from Device / Procedure Related Adverse Events
研究概览
简要总结
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.
详细描述
The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry. The purpose of this clinical study is to describe clinical performance and safety data in a broad patient population treated with the commercially available DiamondTemp™ Family of Cardiac Ablation Catheters (hereafter referred to as the DiamondTemp™ Ablation System) and followed according to the standard of care at each respective institution. The follow up period is intended to align with standard practice and subjects will be followed for a minimum of 12 months post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥ 18 years of age or minimum age as required by local regulations
- •Planned procedure using commercially available DiamondTemp™ Ablation System
- •Willing to comply with study requirements and give IC (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements
排除标准
- •Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
- •Subject with exclusion criteria required by local law
研究组 & 干预措施
Treatment Arm
Patients enrolled and treated with the DiamondTemp™ Ablation System
干预措施: DiamondTemp™ Ablation System (Device)
结局指标
主要结局
Freedom from Device / Procedure Related Adverse Events
时间窗: 12 Months
Estimate serious device and serious procedure-related adverse events for ablation using the DiamondTemp™ Ablation System through 12 months.
Freedom from Recurrence at 12 Months
时间窗: 12 Months
Estimate the 12-month freedom from recurrence of the arrhythmia(s) treated at the study index ablation procedure using the DiamondTemp™ Ablation System.
次要结局
未报告次要终点