A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
- 试验地点
- 53
- 主要终点
- Primary Safety Endpoint
研究概览
简要总结
The study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the FARAPULSE™ Pulsed Field Ablation System, whereby the FARAWAVE NAV Ablation catheter is used in conjunction with the OPAL HDx Mapping System. In addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.
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
- •Subjects are prospectively planned and intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
- •Subjects who are willing and capable of providing informed consent
- •Subjects who are willing and capable of participating to this Registry at an approved clinical investigational center
- •Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law
- •Subjects are planned to undergo an ablation procedure whereby the FARAWAVE NAV PF Ablation Catheter is used in conjunction with the OPAL HDx Mapping System.
排除标准
- •Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. Exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study
结局指标
主要结局
Primary Safety Endpoint
时间窗: 12 months
The Primary Safety Endpoint is defined as the rate of device or procedure related serious adverse events following the index procedure through the 12 Month Follow-up
Primary effectiveness Endpoint
时间窗: 12 Months
The Primary Effectiveness Endpoint is defined as the rate of treatment success, which is defined by Acute and Chronic Procedural Success
次要结局
未报告次要终点