Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous Measurement of Heart Arrythmias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Data collection from the CS6BP watch sensors records , ECG holter and Blood pressure device for the purpose of developing Continuous Measurement of Heart Arrythmias
研究概览
简要总结
The purpose of this clinical study is to collect data simultaneously with the CS6BP watch sensors during EPS in order to characterize different evoked arrhythmias and record Blood Pressure during the procedures that blood pressure is collected by an automated cuff.
详细描述
The proposed clinical study is a Prospective Feasibility, Single-Center Study to collect data simultaneously with the CS6BP watch sensors during EPS or during admission in order to characterize different evoked arrhythmias. Subjects will be screened by the principal investigator or PI's delegate for meeting the study inclusion/exclusion criteria.
Subjects will be fitted with the CS6BP and ECG Holter by Investigator/Study Coordinator during the preparation of the subject to the procedure; when the subject is anesthetized and fitted with an automatic cuff that is preset to measure BP on a frequency as defined in the procedure protocol.
Subjects will be measured simultaneously with CardiacSense device, ECG Holter and EPS recording system if available (- ECG and intracardiac ECG recorded form intra-cardiac catheters). During the EPS the physician will timestamp and mark any provoked arrythmia either on ECG printouts or EPS recording system traces.
The device will be removed once patient has recovered. Subjects candidates for pacemaker implantation will be measured simultaneously with CardiacSense device and ECG Holter before procedure, during patient's hospitalization at cardiology division. At the end of the test the CardiacSense device and ECG Holter will be removed and their data will be downloaded. The recorded ECG (from Holter and if available also EPS recording/ mapping system) data will be analyzed by site staff. The analyzed ECG data will be sent to the company with the CS6BP raw data for further investigation.
BP values will be collected from subjects that are fitted with an automated cuff for BP monitoring for the purpose of evaluation and if required by the physician, during the hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Open-label study
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 of eighteen (18) year and above
- •In clinical need for electrophysiology study (standalone or before ablation procedure) and/or Subjects with AVB who are candidates for pacemaker implantation
- •Ability and willingness to sign an informed consent form
排除标准
- •Patients with significant co morbidities (assessed by the clinician at screening only):
- •Mechanically ventilated patients Mechanical circulation (LVAD, IABP, ECMO)
- •Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
- •Subjects with PPG SNR <100 indicated by the CS6BP device
- •Women who are pregnant or breastfeeding
- •Subjects with had deformity banning from wearing the device
结局指标
主要结局
Data collection from the CS6BP watch sensors records , ECG holter and Blood pressure device for the purpose of developing Continuous Measurement of Heart Arrythmias
时间窗: day 1, procedure day
collection of data from the CS6BP sensors simultaneously with ECG Holter and EPS recorded signals to assess heart arrythmias present during EPS.
次要结局
- Data collection from the CS6BP watch sensors records, ECG holter and blood pressure device for the purpose of developing Continuous Measurement of blood pressure(day 1, procedure day)