Feasibility Testing of a Novel AI-enabled, Cloud-based ECG Diagnostic Solution to Enable Fast and Affordable Diagnosis in Long-term Continuous Ambulatory ECG Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ZBeats INC
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Capturing cardiac arrhythmias and events
研究概览
简要总结
The proposed research is to address the accessibility and affordability of technology to capture symptomatic and asymptomatic cardiac events via Long-Term Continuous Electrocardiogram Monitoring (LTCM), and to provide physicians with full access to their patients' recorded data in a timely manner. We adopt an FDA cleared single- lead OEM patch Holter made of flexible material to make long-term wearing more comfortable and more patient compliant. The patch transmits the recorded data to our cloud-based platform: ZBPro™, where our innovative technologies reside. Our proprietary AI algorithms with innovative human interaction tools, which were developed under the National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I (Award #: 2025951) Award analyze and interpret the recorded data to detect and annotate arrhythmia/cardiac events, and generates daily reports for physician review. The feasibility of our algorithms has been verified using ZBeats' proprietary ECG database based on the standard ANSI/AAMI EC57. Data collection and transmission has been verified in the office environment.
This proposed observational study will utilize a multidisciplinary collaboration of ZBeats Inc. (ZBTS), Stony Brook University (SBU), and Lankenau Medical Center (LMC). The study will enroll patients undergoing ECG monitoring. The primary outcome measure will be the ability to capture cardiac arrhythmias and events from participants. The prescribed FDA-cleared device will serve as the ground truth (GT) for our analyses. The detected arrhythmias and events from our solution will be compared with the findings from the ground truth to obtain our system's detection rate. The goal is to achieve a detection rate of >80% to be deemed successful.
详细描述
The proposed research is to address the accessibility and affordability of technology to capture symptomatic and asymptomatic cardiac events via Long-Term Continuous Electrocardiogram Monitoring (LTCM), and to provide physicians with full access to their patients' recorded data in a timely manner. We adopt an FDA cleared single- lead OEM patch Holter made of flexible material to make long-term wearing more comfortable and more patient compliant. The patch transmits the recorded data to our cloud-based platform: ZBPro™, where our innovative technologies reside. Our proprietary AI algorithms with innovative human interaction tools, which were developed under the NSF SBIR Phase I (Award #: 2025951) Award analyze and interpret the recorded data to detect and annotate arrhythmia/cardiac events, and generates daily reports for physician review. The feasibility of our algorithms has been verified using ZBeats' proprietary ECG database based on the standard ANSI/AAMI EC57. Data collection and transmission has been verified in the office environment.
Specific Aim 1: Study Setup: Setup the study REDCap instance with role-based access under SBU's REDCap system. Prepare data collection forms. Deliver the study devices to clinical sites. Provide training to clinical personnel regarding the study, procedure, informed consent and data collection. Project team assess the protocols and training are in place for the study.
Specific Aim 2: Acceptability Evaluation: Identify and evaluate the device acceptability in up-to-7-day wearing. 60-75 participants will be enrolled during 6-7-month study period. Participants' enrollment, follow-up and closeout questionnaires regarding the acceptability will be conducted in-person or via telephone by the research associate in each clinical site. Success of Aim 2: the mean acceptability percentage of the close-out survey will be > 70%.
Specific Aim 3: Arrhythmia Capture Evaluation: Evaluate devices' ability to detect cardiac arrhythmia and events, as well as the ECG signal quality. Physicians' questionnaire will be completed by the physicians from each clinical site after ZBeats' reports are reviewed and compare with reports generated by the prescription device as the ground truth. The quality of signals will be assessed by an independent cardiologist. Success of Aim 3: the physician's having a 7-day acceptance rate of > 80% and a detection sensitivity of > 80%.
Specific Aim 4: Drafting the study protocol and business plan for Phase II: Conduct statistical analysis, sample size calculations, provide projections, start working on the protocol for Phase II study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who are > 18 years of age
- •Patients who are from one of the clinical collaborators practices
- •Patients who are prescribed to undergo ECG monitoring using an FDA-cleared monitoring device
- •Patients who are post TAVR procedure, a recent history of stroke/TIA, or having cardiac related symptoms
- •Patients who are comfortable using a smartphone or have someone in the home to help with data transmission
- •Patients who have manual dexterity to be able to recharge the phone battery or someone in the home to help them
- •Patients who are English speaking
排除标准
- •Patients who are <18 years of age
- •Patients who are not being prescribed with cardiac monitor testing
- •Patients who refuse to sign informed consent
- •Patients who are unable to provide informed consent
- •Patients who have a pacemaker implanted
- •Patients who are presenting with any dermatitis or infected skin over left anterior thorax
- •Patients who have a history of reaction to a prior cardiac monitor device
- •Patients who are uncomfortable having a cell phone at home for the duration of study participation
- •Patients who non-English speaking
结局指标
主要结局
Capturing cardiac arrhythmias and events
时间窗: 7 days after intervention
The ability to capture cardiac arrhythmias and events from participants will be the primary outcome of this study. The prescribed FDA-cleared device will serve as the ground truth (GT) for our analyses. The detected arrhythmias and events from our solution will be compared with the findings from the ground truth to obtain our system's detection rate. The goal is to achieve a detection rate of \>80% to be deemed successful.
次要结局
- Assessing signal quality(7 days after intervention)
- Assessing user acceptability(7 days after intervention)