An Exploratory Study of Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter Guided by Columbus 3D EP Navigation System in the Ablation Treatment of Paroxysmal Supraventricular Tachycardia（PSVT）
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Immediate ablation success rate
研究概览
简要总结
The purpose of this study was to explore the safety and efficacy of a Pulsed Field Ablation Device and Force Sensing Pulsed Field Ablation Catheter in the treatment of Paroxysmal Supraventricular Tachycardia.
详细描述
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following the last index PFA application with the investigational device
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic paroxysmal supraventricular tachycardia including:Atrioventricular nodal re-entrant tachycardia, Atrioventricular arrhythmias;
- •Willingness to undergo an evaluation to validate the requirements of the protocol.
- •Voluntary signed informed consent and willingness to undergo the tests and procedures required by the protocol.
排除标准
- •Patients with structural heart disease
- •History of any cardiac surgery
- •Failure of prior ablation of PSVT
- •Presence of any implantation, such as artificial valves, permanent pacemakers, etc
- •Patients with active systemic infections
- •Any condition contraindicating septal puncture or retrograde transaortic approach for procedures
- •Any condition contraindicating heparin or aspirin
- •Patients with advanced malignant tumor
- •Any woman known to be pregnant or breastfeeding
- •Unwilling or unable to comply fully with study procedures and follow-up
- •Unable to provide own informed consent
- •Coexistence with other arrhythmias
结局指标
主要结局
Immediate ablation success rate
时间窗: 15 minutes post ablation
The Primary Endpoint for efficacy is the number of subjects where ablation of each PSVT resulted in confirmation of electrical isolation of the PSVT 15 minutes following by catheter mapping and ECG to determine immediate ablation success rate
Rate of Treatment Success at 6-Month Post-Procedure
时间窗: Refers to the postoperative phase after 6 months postoperatively
Refers to the postoperative phase after 6 months follow-up after process,by ECG, Holter, or Heart rate monitoring method based on equivalent confirmed that there are no PSVT events account for the number of participants into the group of the proportion of the total number.
次要结局
- Evaluation of Force Sensing Pulsed Field Ablation Catheter(1 Day of surgery)
- Rate of Treatment Success at 2-Month Post-Procedure(Refers to the postoperative phase after 2 months postoperatively)
- Rate of Treatment Success at 1-Month Post-Procedure(Refers to the postoperative phase after 1 months postoperatively)
- Evaluation of Pulse Ablation equipment(immediately post ablation)
研究者
Caijie Shen
Director
Ningbo No. 1 Hospital