Validation Study: Extended Wear Performance of the Zio Monitor - SHASTA II
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Mean Wear Duration
研究概览
简要总结
This trial assesses the wear performance of the Zio monitor, a long-term continuous ambulatory patch ECG monitor, in a representative population by evaluating (1) the wear duration (up to 30 days) of the device, (2) the percentage of analyzable electrocardiographic time and (3) safety by reviewing all adverse events.
详细描述
This is a prospective, multi-center, single-arm study to validate the design of the Zio monitor/Zio MCT device form factor in extended (21-day) wear when utilizing an updated skin prep process.
The trial is conducted in 2 phases. Phase I includes the standard skin preparation process of 40 strokes with an exfoliator in 4 different directions. Phase II incorporates a modified skin preparation process: only 20 strokes with an exfoliator in 2 directions are used. There are 75 participants in each phase.
Performance objectives include the following: (1) Mean wear duration of 21 days and (2) percent analyzable time of 80%.
Safety measures include the proportion of participants that experience clinically significant skin irritation through 30 days of wear, as well as the reporting of all adverse events.
Additional device measures include the following: (1) % signal artifact (defined as the proportion of ECG signal that is artifact over the wear duration, reported for each study device); (2) % device functionality (defined as the proportion of Zio monitors recording a continuous ECG signal through 21 days, and through 30 days) and (3) observational assessment of participant skin types (assessed by dryness levels, hyperhydrosis status, Fitzpatrick Skin Type and chest hair density).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be 18 years or older at time of informed consent.
- •Participant is willing and able to provide informed consent and be able to complete all visits for the study.
排除标准
- •Participant has a known allergy to adhesives.
- •Participant has a current skin infection or injury at location for study device placement.
- •Participant is a member of a vulnerable population.
- •Participant is a current or prior employee of iRhythm.
- •Participant is unable or unwilling to participate or comply with study protocol.
- •The local Investigator deems the participant has a condition that could limit the participant's ability or willingness to participate in the study, or ability to comply with study required procedures and/or follow-up visits.
- •Participant has experienced symptomatic episodes where instance variations in cardiac performance could result in immediate danger to the participant.
- •Participant has an external cardiac defibrillator or may be exposed to high frequency surgical equipment near strong magnetic fields or devices such as MRI during the wear period.
- •Participant has a neuro-stimulator, as it may disrupt the quality of ECG data.
- •Participant does not have the competency to wear the device for the prescribed monitoring period.
- •Participant does not have the ability to consent for themselves (i.e., no LARs).
研究组 & 干预措施
Open Label - Phase I Participants
This is an open-label study conducted in 2 phases. All participants (75 in Phase I) will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
干预措施: Zio Monitor (Device)
Open Label - Phase II Participants
This is an open-label study conducted in 2 phases. All participants (75 in Phase II) will have the study device applied to their chest. Two-thirds of the participants will have the study device applied by a Study Staff member (i.e., Healthcare Provider (HCP)). One-third of the participants will self-apply the study device to their chest (i.e., simulated at-home patch application). Application of all study devices will be performed at the site.
干预措施: Zio Monitor (Device)
结局指标
主要结局
Mean Wear Duration
时间窗: 21 - 30 days after baseline
This outcome measure is met if the mean wear duration is greater than 21 days
Percent Analyzable Time
时间窗: Up to 30 days (Day 30)
This outcome measure is met if the percent analyzable time is greater than 80% in 90% of subjects.
Safety: Skin Irritation
时间窗: Up to 30 days (Day 30)
This includes the proportion of participants that experience clinically significant skin irritation through 30 days of wear. This will be assessed through the capture and reporting of all adverse events.
Mean Wear Duration
时间窗: 21 - 30 days after baseline
This outcome measure is met if the mean wear duration is greater than 21 days
Percent Analyzable Time
时间窗: Up to 30 days (Day 30)
This outcome measure is met if the percent analyzable time is greater than 80% in 90% of subjects.
Safety: Skin Irritation
时间窗: Up to 30 days (Day 30)
This includes the proportion of participants that experience clinically significant skin irritation through 30 days of wear. This will be assessed through the capture and reporting of all adverse events
次要结局
- Additional Device Measure 1: Percent Signal Artifact(Up to 30 days (Day 30))
- Additional Device Measure 2: Percent Device Functionality(At 21 days (Day 21) and 30 days (Day 30))
- Observational Assessment: Skin Dryness Level(Baseline (Day 1))
- Observational Assessment: Hyperhydrosis Status(Baseline (Day 1))
- Observational Assessment: Fitzpatrick Skin Type(Baseline (Day 1))
- Observational Assessment: Chest Hair Density(Baseline (Day 1), 21 days (Day 21) and 30 days (Day 30))
- Additional Device Measure 1: Signal Artifact(Up to 30 days (Day 30))
- Additional Device Measure 2: Device Functionality(At 21 days (Day 21) and 30 days (Day 30))
- Observational Assessment: Chest Hair Density(Baseline (Day 1))
- Additional Device Measure 1: Percent Signal Artifact(Up to 30 days (Day 30))
- Additional Device Measure 2: Percent Device Functionality(At 21 days (Day 21) and 30 days (Day 30))
- Observational Assessment: Skin Dryness Level(Baseline (Day 1))
- Observational Assessment: Hyperhydrosis Status(Baseline (Day 1))
- Observational Assessment: Fitzpatrick Skin Type(Baseline (Day 1))
- Observational Assessment: Chest Hair Density(Baseline (Day 1), 21 days (Day 21) and 30 days (Day 30))