Risk of Asymptomatic Cerebral Embolism During Atrial Fibrillation Ablation Using Smart Touch SF Catheter With Ablation Index Guided High-power Short-duration Strategy Versus Smart Touch Catheter With Standard Settings Evaluated by High-resolution Diffusion-weighted Magnetic Resonance Imaging Technique (REDUCE-IT Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.
研究概览
简要总结
The purpose of this prospective randomized controlled study is to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted magnetic resonance imaging technique.
详细描述
Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is associated with the occurrence of procedure-related thromboembolic events, especially the risk of asymptomatic cerebral embolism detected by brain high-resolution diffusion-weighted magnetic resonance imaging (hDWI). Meanwhile, ablation index guided high-power short-duration (AI-HPSD) strategy with the advanced SmartTouch SurroundFlow (STSF) catheter is an increasingly used technique for catheter ablation of AF, which is proposed to be associated with relatively wider and superficial lesions, less risk of esophageal injury, and shorter procedure time plus higher rate of first-pass pulmonary vein isolation. Moreover, the advanced STSF catheter in AI-HPSD strategy features with the Surround Flow entire tip irrigation system, which is a wide-spread distribution of the irrigating solution (56 irrigation holes), resulting in homogenous cooling and protection from thrombus formation and reduced incidence of steam pops. Thus, comparing with the standard radiofrequency ablation technique using the SmartTouch (ST) catheter, the AI-HPSD strategy may associate with much lower risk of periprocedural asymptomatic cerebral embolism, with the application of advanced STSF catheter and shorter procedure time. Therefore, this study is designed as a prospective randomized controlled study to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of AF with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain hDWI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients≥18 years of age prior to obtaining the written informed consent.
- •Patients with electrocardiographically documented, symptomatic atrial fibrillation.
- •Patients is scheduled to undergo circumferential pulmonary vein antrum radiofrequency ablation.
- •Patient or patient's legal representative is able and willing to give informed consent.
排除标准
- •Moderate to severe valvular heart disease.
- •Contraindication for anticoagulation therapy.
- •Contraindication for Diffusion-Weighted MRI.
- •Ischemic stroke or transient ischemic attack within 6 months prior to the consent date.
- •Acute coronary syndrome within 3 months prior to the consent date.
- •Prior left atrial appendage occlusion device.
- •Prior septal occlusion device.
- •Left atrial size greater than 55 mm.
- •Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion).
- •Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study.
- •Simultaneous participation in another study.
- •Unwilling or unable to comply fully with the study procedures and follow-up requirements.
结局指标
主要结局
The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.
时间窗: Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.
The brain hDWI should be performed within 3 days prior to the ablation procedure to investigate previous cerebral lesions and reevaluated within 24-72 hours post ablation to determine the occurrence of new asymptomatic cerebral embolic lesions. The acute cerebral embolic lesion is typically defined as a new focal hyper-intense area detected on the diffusion-weighted sequence, and a hyper-intense signal intensity in the fluid-attenuated inversion recovery sequence, and meantime confirmed by apparent diffusion coefficient mapping as corresponding area of restricted diffusion to rule out a shine-through artifact.
次要结局
- Cognitive functional status evaluated using the Montreal Cognitive Assessment (MoCA) test.(On the 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.)
- Overall complication rate during catheter ablation and up to 3 months follow up.(3 months after the catheter ablation procedure.)
研究者
Yuehui Yin
Professor
The Second Affiliated Hospital of Chongqing Medical University