A pilot prospective study to evaluate Electrocardiogram (ECG) signal acquisition and functionality of newly developed External Cardiac Monitoring (ECM) prototype
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- The primary objective of the study to evaluate the quality of the ECG signal acquisition to assess the incidence of cardiac arrhythmia during short-term (up to 24hrs) and long-term monitoring (for 3 months), via Group A and Group B studies respectively.
研究概览
简要总结
Cardiac arrhythmias such asAtrial Fibrillation (AF) and sinus node disease usually can be silent,
intermittent and asymptomatic innature. The current recommended practice of 24 hours
Electrocardiogram (ECG)recording could miss significant arrhythmia requiring therapeutic intervention
. This results in low diagnosticyield and inferior clinical outcome for the patient. An extended
Continuous Cardiac Monitoring(CCM) duration can improve diagnostic yield for diseases with
intermittent symptoms orasymptomatic arrhythmias (syncope, palpitations or unexplained stroke) and
can provide a clear picture tothe severity for diseases such as atrial fibrillation to help in the guidanceof
appropriate medical management.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Above 18 years of age 2) Patients with the previous history of cardiovascular disease 3) Patients with a previous history of cardiovascular disease (or) suspected (or) increased risk of cardiac arrhythmia in the setting of unexplained syncope, cryptogenic stroke or with transient symptoms of dizziness, palpitations, or chest pain 4) Enroll only In-patients who can complete for the Group A study 5) The subject is willing to sign the Informed consent form.
排除标准
- •Patients implanted with Cardiac Implantable Electronic Device (CIED) (e.g., IPG, ICD, CRT, etc.) 2) Any high-risk patient who is already implanted or needs an implant with other life sustaining equipment during the course of study, that may interfere with the function of Cardilinq External Cardiac Monitor(ECM) prototype should be excluded as per physician discretion 3) Patients with a history of sweat allergy 4) Patients with prior evidence of skin irritation or symptoms of skin infection OR wound at any point where the ZephyrTM Bioharness chest strap will contact the subject 5) Female patients who are pregnant and breastfeeding 6) Not willing to consent.
结局指标
主要结局
The primary objective of the study to evaluate the quality of the ECG signal acquisition to assess the incidence of cardiac arrhythmia during short-term (up to 24hrs) and long-term monitoring (for 3 months), via Group A and Group B studies respectively.
时间窗: 24 hours
次要结局
- -To assess the patient comfort level and compliance with the prototype use while being continuously monitored for 3 months.(-To assess the functionality of the prototype in acquiring ECG data for a period of 3 Months.)