Clinical Validation of the Perin Health Patch Electrocardiogram Monitoring Device: A Multi-Component Study Evaluating Signal Quality, Placement Tolerance, and Long-Term Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- ECG Timing Interval Equivalence Between Perin Health Patch and Reference Holter Monitor
研究概览
简要总结
The goal of this clinical trial is to test how accurately and reliably a new chest-worn device called the Perin Health Patch measures heart rhythms (ECG) in adults aged 22 and older. The main questions it aims to answer are:
- How accurately does the Perin Health Patch measure heart rhythm compared to standard hospital ECG monitoring equipment?
- Does the patch still work properly if it's placed slightly off from the exact recommended position on the chest?
- Does the patch maintain good performance when worn continuously for 15 days?
The study has three parts that test different aspects of the device. Participants will:
- Wear the Perin Health Patch on their chest along with standard ECG monitoring equipment for comparison
- Have ECG recordings taken while sitting quietly for 15 minutes
- For the placement study: have the patch placed in several different positions to test if small placement errors affect performance
- For the long-term study: wear the patch continuously for 15 days at home with regular check-ups on days 1, 7, 10, and 15
The study will include both healthy adults and people with heart or lung conditions like heart failure, COPD, high blood pressure, or diabetes to test how well the device works for different types of patients. Researchers will compare the heart rhythm measurements from the chest patch to standard medical monitoring equipment to determine if the patch is accurate enough for medical use. Some participants will complete just one part of the study, while others may participate in multiple parts depending on which aspect of the device is being tested.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 22 to 90 years of age
- •Healthy or chronic cardiopulmonary conditions or recent procedures
- •Able to comply with study procedure
排除标准
- •Pediatric or adolescent patients (age ≤21 years)
- •Pacemaker
- •A history of skin reactions to medical adhesives
- •Any psychosocial condition or circumstance that, in the opinion of the investigator, would interfere with the conduct of the study or the patient's care and/or safety
- •Current participation in any other clinical study
- •Refusal to participate
结局指标
主要结局
ECG Timing Interval Equivalence Between Perin Health Patch and Reference Holter Monitor
时间窗: During single 15-minute recording session and up to 15 days of continuous monitoring
Equivalence of ECG measurements between the investigational chest patch and FDA-cleared Holter monitor using Two One-Sided Tests (TOST) statistical methodology. ECG recordings are taken simultaneously from both devices while participants sit quietly for comparison. Equivalence is demonstrated when confidence intervals for mean differences fall within pre-specified clinical margins for key ECG timing intervals including QT interval, QRS duration, and R-R interval. Signal morphology similarity is assessed using Pearson correlation coefficient (where 1.0 indicates perfect similarity) and normalized root mean square error (where 0% indicates identical signals).
次要结局
- Heart Rate Measurement Accuracy(During single 15-minute recording session and up to 15 days of continuous monitoring)
- ECG Signal Quality Equivalence(During single 15-minute recording session and up to 15 days of continuous monitoring)
- Device Adhesion Success Rate During Extended Wear(Over 15-day continuous monitoring period)