一个前性的,多中心的,随机的,受控的试验的协议,比较在患有持续心房的患者中脉冲野外切除与冷热气球切除 (PEACE试验)
Hidehira Fukaya1, Jun Oikawa2, Tomoharu Yoshizawa3
1Department of Cardiovascular Medicine, Kitasato University School of Medicine, Kanagawa, Japan.
International journal of cardiology. Heart & vasculature
|October 23, 2025
概括
脉冲场切除 (PFA) 显示出持续性心房动 (PeAF) 的前景. 该PEACE试验将将PFA与冷热气球除 (CBA) 进行比较,评估其在PeAF患者中的有效性和安全性.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 临床试验 临床试验
背景情况:
- 导管切除是心房动 (AF) 的标准治疗方法.
- 有限的证据存在于脉冲场切除 (PFA) 在持久性AF (PeAF) 的有效性和安全性.
研究的目的:
- 在患有PeAF的患者中,评估PFA的疗效和安全性与冷热气球除 (CBA) 相比.
- 为了确定PFA是否不劣于CBA治疗PeAF.
主要方法:
- 未来的,多中心的,随机对照的,非劣等性试验 (PEACE试验).
- 300名患有PeAF的患者随机分配 (1:1) 给PFA (PulseSelectTM) 或CBA (北极战线先进TM).
- 主要终点:心房动脉节律衰退复发 (12个月) 和与手术相关的并发症 (30天).
主要成果:
- 假设:PFA在有效性和安全性方面不会低于CBA.
- 主要疗效终点:12个月后心房动脉节律衰竭复发.
- 主要安全终点:在30天内与手术相关的并发症.
结论:
- 和平试验将为PeAF提供PFA与CBA的关键数据.
- 结果可能会为持续性AF切除提供未来临床实践指南.
更多相关视频
08:00Reduction of Iatrogenic Atrial Septal Defects with an Anterior and Inferior Transseptal Puncture Site when Operating the Cryoballoon Ablation Catheter
Published on: June 15, 2015
14.4K
06:48Three-Dimensional Echocardiographic Method for the Visualization and Assessment of Specific Parameters of the Pulmonary Veins
Published on: October 28, 2020
3.2K
相关概念视频
Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
