A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch® Extended Wear Holter vs. Standard Wear Holter
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Diagnostic yield (frequency) of clinically actionable arrythmia
研究概览
简要总结
This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring.
详细描述
This study is a multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring. Approximately 256 adult subjects with symptoms of syncope will be randomized 1:1 to wear either the Philips ePatch Extended Wear Holter (7 day) or Standard Wear Holter (24 hours). Randomization will be balanced for gender.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 old
- •Recommended for ambulatory cardiac Holter monitoring due to symptoms of syncope
- •Able to comply with continuous ECG monitoring for up to 7 days
- •Able and willing to replace the Patch electrode at home
- •Capable of providing voluntary informed consent and mentally and physically willing and able to be compliant with the protocol, including the follow-up visit(s)
排除标准
- •Patient with chronic Atrial Fibrillation (AF)
- •Patient with implanted pacemaker/defibrillator
- •Patient with known allergy to adhesive materials and/or hydrogel
- •Patient with broken, damaged, or irritated skin where ECG patch will be placed
研究组 & 干预措施
ePatch® Extended Wear Holter (EWH) Arm
Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration
干预措施: ePatch ® Extended Wear Holter (EWH) (Device)
Standard of Care
Participants will undergo 24 hours of continuous ECG recording.
结局指标
主要结局
Diagnostic yield (frequency) of clinically actionable arrythmia
时间窗: Up to 7 days
In patients indicated for cardiac monitoring due to syncope, show that the diagnostic yield (frequency) of clinically actionable arrythmia with 7 days of monitoring using the ePatch Extended Wear Holter is superior to what would be seen with the Standard Wear Holter (24 hours).
次要结局
- Number of Clinically actionable arrhythmia(Up to 7 days)
- Patient Quality of Life as measured by EQ-5D-5L(Up to 7 days)
- Patient Quality of Life as measured by Patient Experience Survey(Up to 7 days)
- Number of Atrial Fibrillation (AF) diagnoses > 30 seconds(Up to 7 days)
- Occurrence of symptomatic events(Up to 7 days)
- Cost related to cardiac monitoring(Up to 7 days)
- Time Holter is worn/ removed(Up to 7 days)
- Number of Atrial Fibrillation (AF) diagnoses > 30 seconds(Up to 7 days)
- Occurrence of symptomatic events(Up to 7 days)
- Number of Clinically actionable arrhythmia(Up to 7 days)
- Patient Quality of Life as measured by EQ-5D-5L(Up to 7 days)
- Patient Quality of Life as measured by Patient Experience Survey(Up to 7 days)
- Cost related to cardiac monitoring(Up to 7 days)
- Time Holter is worn/ removed(Up to 7 days)