Reveal LINQ Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 16
- 主要终点
- Success of Wireless Transmissions
研究概览
简要总结
The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor
详细描述
The Reveal LINQ Usability Study is a prospective, non-blinded, non-randomized, multi-center clinical trial. Subjects will transmit device data via manual interrogation on a weekly basis during the first month and will be evaluated in the office at 1-month post-implant, in addition to an automatic nightly wireless data transmission using the MyCareLink® home monitor. All subjects will be requested to wear an external Holter for 48 hours at approximately 4 weeks post-insertion. Follow-up visits will continue at 6 and 12 months post-implant, with monthly manual interrogations. Subjects will be exited at their 12 month follow-up visit. The overall study will be conducted in 2 phases which differ primarily on inclusion criteria: Phase I subjects (initial 30 subjects) will have any indication for an ICM, Phase II subjects (all subjects following the initial 30 subjects) will be atrial fibrillation (AF) pre-ablation patients. The study will assess functionality of the Reveal LINQ device by assessing sensing performance and data transmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is willing to sign and date the consent form.
- •Subject is indicated for a Reveal device within the existing market approved indications
- •Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device
- •Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is indicated for and identified as an AF pre-ablation candidate*
- •*Note: Atrial fibrillation must be documented in the subject's medical history.
- •Subject has a life expectancy of 18 months or more.
- •Subject is willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored (i.e., Medtronic CareLink® Network)
- •Subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must:
- •have a negative pregnancy test at enrollment.
- •not be breastfeeding.
- •either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.
排除标准
- •Subject has an active implanted cardiac medical device (e.g., IPG, ICD, CRT, etc).
- •Subject is unwilling or unable to comply with the study procedures
- •Subject is legally incapacitated and unable to provide written informed consent.
- •Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis)
- •Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager.
- •Local law prohibits participation (e.g., minor status as specified by local law)
研究组 & 干预措施
Insertable Cardiac Monitor Implant
干预措施: Insertable Cardiac Monitor Implant (Device)
结局指标
主要结局
Success of Wireless Transmissions
时间窗: 30 days
To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
R-wave Amplitude
时间窗: 30 days
To characterize the signal quality of the R-wave amplitude at implant and one month.
R-wave Amplitudes Greater Than or Equal to 200 μV
时间窗: 30 days
The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.
次要结局
- Accuracy of Reveal LINQ Device Detected Atrial Fibrillation(4 months)
- Survey of the Implanting Physicians(Day of implant)
- Safety Endpoint(12 months)
- Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor(48 hours)
- Survey of the Patient Experience Over Time(12 months)