NCT04025710已完成不适用
BIO|MASTER.BIOMONITOR III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 27
- 主要终点
- SADE-free Rate Until the 3-month Follow-up
研究概览
简要总结
This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at high risk of developing a clinically important cardiac arrhythmia; or
- •Patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
- •Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
- •Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
- •Patient is able to understand the nature of the study and able to provide written informed consent.
- •Patient is willing and able to perform all follow-up visits at the investigational site.
- •Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept.
排除标准
- •Patient is implanted with an ICD or pacemaker.
- •Patient is pregnant or breast-feeding.
- •Patient is less than 18 years old.
- •Patient's life-expectancy is less than 12 months.
- •Patient is participating in another interventional clinical investigation.
结局指标
主要结局
SADE-free Rate Until the 3-month Follow-up
时间窗: 3 months
SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
次要结局
- Noise Burden(10 days to 4 weeks after insertion; 3-months)
- R-wave Amplitude(10 days to 4 weeks after insertion; 3-months)
- SADE-free Rate Until the 12-month Follow-up(12-months)
- Assessment of P-wave Visibility(10 days to 4 weeks after insertion; 3-months)
研究者
研究点 (27)
Loading locations...
相似试验
撤回
不适用
PMCF Study for Partial Vision Restoration Using the Subretinal Implant RETINA IMPLANT Alpha AMSRetinitis PigmentosaNCT02588430Retina Implant AG
Unknown
不适用
Micro Plug Set - Post Market Clinical Follow-up (PMCF) PlanTrauma InjuryBleedingNCT04218292KA Medical, LLC40
已完成
不适用
PMCF Study for Cardiology Access ProceduresCoronary Artery DiseaseNCT05543096Cordis Corporation200
招募中
不适用
Post-market Clinical Follow-up (PMCF) Study of the Infinity-Lock Button System for Acromioclavicular Joint StabilisationDislocation AcromioclavicularNCT05397210Xiros Ltd58
Enrolling By Invitation
不适用
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCKKnee OsteoarthritisNCT04145401MicroPort Orthopedics Inc.45