Clinical Benefit, Long Term Effectiveness, and Safety Outcome of Paroxysmal Atrial Fibrillation Ablation Using THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Paroxysmal Atrial Fibrillation
- 发起方
- Biosense Webster, Inc.
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
- 状态
- 进行中（未招募）
- 最后更新
- 19天前
概览
简要总结
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.
详细描述
The purpose of this study is to measure the long term effectiveness，clinical benefit, and safety outcomes of catheter ablation with STSF and AI for paroxysmal atrial fibrillation (PAF) subjects up to 12-month follow-up. Subject:Up to 150 PAF subjects will be included in the study data, representing all consecutive subjects having catheter ablation with AI guiding STSF and for the treatment of PAF at the site. Primary endpoint: The primary endpoint is freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure. Secondary endpoint : Acute success at 0.5hour CPVI (i.e. entrance block achieved in all veins, verified via an isoproterenol intravenous challenge) * Numbers of reconnected pulmonary veins (PV), with number and location of any gaps * Procedural efficiency measures（e.g. mapping time, ablation time, total procedure time, and fluid volume delivered via catheter. * AI values * Inter-Tag distances * Adverse events (Complications related to device or procedure) * Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year Clinical Study Sites: Shanghai General Hospital Study Duration: 18-month enrollment period, with follow-up at 3, 6 and 12 months after ablation, with a blanking period defined as the period within 90 days after the ablation.
研究者
入排标准
入选标准
- •Age 18 years or older
- •Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements
- •Able to sign EC-approved informed consent form
排除标准
- •AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
- •Patient has AF episodes lasting longer than 7 days
- •History of heart surgery, or any previous ablation for AF
- •Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
- •Documented left atrial thrombus on imaging
- •New York Heart Association (NYHA) class III or IV heart failure
- •Hypertrophic obstructive cardiomyopathy
- •Presence of implantable cardioverter defibrillator (ICD)
- •Contraindication to isoproterenol
- •Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
结局指标
主要结局
Rate of freedom from documented atrial fibrillation (AF), atrial tachycardia (AT), or atrial flutter (AFL) (≥30 seconds) within 91-365 days post index procedure.
时间窗: 91-365 days
Atrial tachyarrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
次要结局
- Numbers of reconnected pulmonary veins (PV), with number and location of any gaps(91-365 days)
- Ablation time(91-365 days)
- Rate of adverse events occurred(91-365 days)
- RF ablation and fluoroscopy times in seconds(91-365 days)
- Fluid volume delivered via catheter(91-365 days)
- Mapping time(91-365 days)
- Ablation times in seconds(91-365 days)
- Rate of acute success at 0.5hour CPVI(91-365 days)
- Contact force in grams(91-365 days)
- Re-hospitalization due to arrhythmia recurrence or procedure-related reasons up to 1 year(91-365 days)
- Total procedure time(91-365 days)
- Inter Tag in micrometers(91-365 days)