Ablation With FARAPULSE and Left Atrial Appendage Closure With Watchman for Integrated Management of Atrial Fibrillation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 26
- 主要终点
- The occurrence of events between the time of implant and within 7 days following the procedure
研究概览
简要总结
This sub-study is a prospective/retrospective, non-randomized, observational, comparative cohorts study, embedded in and expanding on the infrastructure of a real-world AF ablation registry DISRUPT-AF (NCT06335082).
详细描述
The prospective arm of the sub-study is intended to enroll 120 subjects indicated for PFA and Watchman in up to 20 US sites within the framework of the DISRUPT-AF registry. Subjects will be screened for eligibility to participate in concomitant PFA ablation for AF and LAAC by Watchman FLX Pro device in a single procedure. Both PVI and LAAC procedures are performed per SOC. In general, percutaneous catheterization will be initially established using FARADRIVE™ steerable sheath for ablation treatment of AF using the FARAWAVE Catheter per instruction for use (IFU) of the device and operator's standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. After AF ablation, the FARAWAVE Catheter will be withdrawn. The FARADRIVE™ steerable sheath will be replaced with Watchman FLX deployment sheath. Deployment of Watchman FLX Pro device to LAA to achieve LAAC will follow the standard practice of the care and IFU of the device. Patients will be followed up at 45-90 days for LAAC implant assessment and at 3, 6, and 12 months for arrhythmia recurrence assessment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All inclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study must meet the additional inclusion criteria below:
- •Patients who are determined by physicians to be eligible for LAAC
- •Patients whose LAAC with Watchman FLX Pro procedures are performed concomitant following AF ablation procedure
- •Willing and able to provide additional informed consent to the sub-study (unless waiver of consent is obtained)
排除标准
- •All exclusion criteria of the main DISRUPT-AF registry will apply. In addition, patients included in this sub study have the additional exclusion criteria below:
- •Patients who are participating in other DISRUPT-AF sub-studies
研究组 & 干预措施
Combining LAAC and PFA ablation procedures
AF ablation and LAAC procedures are performed per operators' standard practice. AF ablation will include PVI. Additional right or left atrial ablations are per investigators' discretions. Both AF ablation and LAAC procedures may be performed with ICE or TEE. Assessment of LAAC peri-device leaks and device-related thrombi at 45-90 days may be performed with TEE or cardiac computed tomography angiography (CCTA).
干预措施: Watchman FLX™ Pro device. (Device)
结局指标
主要结局
The occurrence of events between the time of implant and within 7 days following the procedure
时间窗: 12 months
AF ablation safety will be compared between the concomitant procedures and standalone AF ablation cohort. and LAAC procedure safety will be compared between the concomitant procedures and standalone LAAC cohort.
次要结局
- LAAC success and late-onset safety(12 months)