Clinical Trial for Pre-market Registration of Biotronik Qubic Stim Cardiac Stimulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 3
- 主要终点
- Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)
研究概览
简要总结
106 subjects selected from 3 study sites in China are with indications for intracardiac electrophysiological examination. The trial is to prove the clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese population.
详细描述
The trial is a multicenter, prospective and single-arm study. 106 appropriate subjects were selected from 3 study sites in China in accordance with the inclusion and exclusion criteria. The subjects consent to participate in the trial and sign the informed consent. The subjects who meet the inclusion and exclusion criteria will receive the intracardiac electrophysiological examination, during which the subjects will be subject to diagnostic electrical stimulation by the Qubic Stim Cardiac Stimulator. The subjects will also receive the clinical follow-up visit after cardiac electrical stimulation until they are discharged from the hospital. The clinical effectiveness and safety of Qubic Stim Cardiac Stimulator in Chinese population were proved by observing the data collected in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years
- •Subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site.
- •Subjects with an indication of the intracardiac electrophysiological examination(fit one of the following):
- •Paroxysmal supraventricular tachycardia: atrioventricular reentrant tachycardia or atrioventricular node reentrant tachycardia or atrial tachycardia.
- •Ventricular arrhythmia: Premature ventricular contraction or ventricular tachycardia.
- •Atrial fibrillation.
- •Atrial flutter.
排除标准
- •Previous cases of unsuccessful radiofrequency ablation or recurrence
- •Pregnant and/or lactating women
- •Acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination
- •Liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination
- •Obvious bleeding tendency or blood system disease
- •Cancer and terminal disease
- •Combined with severe organic cardiovascular disease
- •Cerebral apoplexy and other cerebrovascular diseases within the past 3 months
- •Thromboembolic disease
- •Subjects who are participating in other interventional clinical trials
研究组 & 干预措施
Single Arm ( Qubic Stim Cardiac Stimulator )
There is only one Arm in this trial, the subjects who meet the inclusion and exclusion criteria will receive the intracardiac electrophysiological examination, during which the subjects will be subject to diagnostic electrical stimulation by the Qubic Stim Cardiac Stimulator. The subjects will also receive the clinical follow-up visit after cardiac electrical stimulation until they are discharged from the hospital.
干预措施: Cardiac Stimulator (Device)
结局指标
主要结局
Count of Participants With Paced Successfully by Programmed Extrastimulation (PES)
时间窗: during the procedure
The expected clinical effect: the heart is effectively paced by PES at a set rate of stimulation. After the release of electrical stimulation, the stimulation signal can produce an effective cardiac pacing wave. The asymptotic normal method is an estimator whose limiting distribution is normal when the sample size n increases indefinitely. For example, the sample mean and sample moment are asymptotically normal estimators. Under a wide range of conditions, the maximum likelihood estimators of unknown parameters are asymptotically normal estimators. The exact probability method is a statistical test used to determine whether there is a non-random correlation between two variables. The asymptotic normal method and the exact probability method were used to estimate the 95% confidence interval of success rate of diagnostic electrical stimulation performed by heart stimulator.
Success Rate of Sinus Node Recovery Time (SNRT) Could be Measured.
时间窗: during the procedure
Calculate the percentage of subjects who had successful sinus node recovery time (SNRT) measurements out of the total number of subjects.
High Rate (Burst) Stimulating Successful Rate
时间窗: during the procedure
Calculate the percentage of subjects who responded successfully to burst stimulation out of the total number of subjects.
次要结局
- Serious Device Adverse Events Caused by Cardiac Stimulator(from the intracardiac electrophysiological examination to discharge, an average of three days)