Pulse Field Ablation Based Pulmonary Vein Isolation Concomitant With Left Atrial Appendage Closure - The COCONUT II Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- • Primary efficacy endpoint: Acute success of PVI and LAA closure
研究概览
简要总结
A multicenter, prospective registry of concomitant Farapulse (Boston scientific) based PVI and Watchman Flx device (Boston scientific) based LAAC procedures was planned in order to assess the acute and mid-time safety, efficacy and efficiency of this approach (COCONUT II study). If available the transseptal puncture will be performed by the VersaCross System (Boston scientific). If already available LAAC procedure will be performed utilizing the Watchman Flx pro device (Boston scientific) or the Watchman Flx device (Boston scientific).
For procedure planning, assessment of the LAA size and selection of the Watchman Flx device a preprocedural cardiac computed tomography in combination with the TruePLan Software is recommended.
详细描述
The objective is to invite high-volume centers in Germany to submit the procedural and periprocedural data, as well as the 12-months follow-up data in a secure and standardized way. In comparison to the most registries conducted today, a dedicated database comprising a standardized questionnaire, as well as multiple data validation processes at different levels in order to assure a better data quality is used.
The aim of the COCONUT II study will collect data of a concomitant PFA based PVI and LAAC approach to treat AF and prevent bleeding and stroke within 12 months. Furthermore, economic factors could be beneficial due to only one concomitant procedure with one hospital stay instead of two procedures with two hospital stays.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years
- •Willing to participate
- •Atrial fibrillation and indication for PVI (ESC guideline 2024)
- •Indication for OAC therapy (CHA2DS2VA score >/=2)
排除标准
- •Contraindications for PVI and / or LAA closure
- •Pregnancy
- •Previous catheter ablation for AF
研究组 & 干预措施
Concomitant PVI plus LAAC
干预措施: Interventional LAA Closure (Procedure)
Concomitant PVI plus LAAC
干预措施: Pulmonary vein isolation (Procedure)
结局指标
主要结局
• Primary efficacy endpoint: Acute success of PVI and LAA closure
时间窗: 30 days
• Primary efficiency endpoint: Duration of hospital stay (nights) within 30 days
时间窗: 30 days
• Primary safety endpoint: Major complications, (SAE) within 30 days
时间窗: 30 days
次要结局
未报告次要终点
研究者
Prof. Christian-Hendrik Heeger
Prof. Dr.
Asklepios proresearch