A Real-world Study of Cardiac Ablation for Paroxysmal Supraventricular Tachycardia Using THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter（ST in PSVT-RWS）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Incidence of primary adverse events (PAE)
研究概览
简要总结
Paroxysmal supraventricular tachycardia known as PSVT includes atrioventricular reentrant tachycardia (AVRT) and atrioventricular nodal reentrant tachycardia (AVNRT).
This study is multicenter, retrospective, cohort study. This study will collect real world data of AVNRT and AVRT cohorts retrospectively to evaluate the effectiveness and safety in real world clinical practice. 300 subjects with PSVT will be consecutively enrolled backwards since 02 Nov 2017, and at least 100 subjects for each cohort.
Cohort one: AVNRT Cohort two: AVRT, including Wolff-Parkinson-White syndrome（WPW）
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Waiver of informed consent is approved by Ethics Committee, or follow methods approved by Ethics Committee to get patient's informed consent (such as get informed consent by telephone contact, etc.).
- •Patients diagnosed as atrioventricular reentrant tachycardia (AVRT), atrioventricular node reentrant tachycardia (AVNRT) after surgery/discharge, and the existing source records must include 1) at least 1 copy of preoperative ECG or intraoperative electrophysiological examination results;2) Information about the acute procedure outcome.
- •Patients were ablated by ST catheter.
- •Adult patients 18 years or older.
排除标准
- •Contraindications for the use of ST catheters, including:
- •Ventriculotomy or atriotomy was performed within 8 weeks before the procedure;
- •Presence of myxoma or intracardiac thrombus;
- •fitted with artificial valves;
- •Active systemic infection;
- •Atrial septal patch.
- •Pregnant women
结局指标
主要结局
Incidence of primary adverse events (PAE)
时间窗: From procedure to pre-discharge (an average of 2-3 days)
Primary adverse events include device or procedure related death, myocardial infarction, atrioventricular block, thrombosis, stroke/cerebral vascular accidents (CVA), tamponade/perforation, transient ischemia attack (TIA), pericarditis, major vascular complications/bleeding, Adverse Event which prolonged hospitalization due to non-arrhythmic causes.
Acute success rate of PSVT ablation using ST Catheter
时间窗: Intra-procedure
Acute success rate is defined as accessory pathway/slow pathway blockade immediately after ablation, and drug and/or electrophysiological stimulation no longer induces clinical arrhythmias.
次要结局
- The proportion of patients who did not develop PSVT recurrence(from discharge to the follow-up visit (an average of 4-6 years))
- Incidence of serious adverse events(from discharge to the follow-up visit (an average of 4-6 years))
- Acute success rate of cardiac ablation for AVNRT using ST catheter(Intra-procedure)
- Acute success rate of cardiac ablation for AVRT using ST catheter(Intra-procedure)