ACTRN12618001950257尚未招募不适用
Implantation and signal assessment of BioMonitor III in patients with suspected arrhythmias or symptoms suggestive of arrhythmic causes
BIOTRONIK Australia Pty. Ltd.0 个研究点目标入组 45 人开始时间: 2018年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Patient is at high risk of developing a clinically important cardiac arrhythmia; or
- •2. Patient is undergoing investigation for symptoms such as palpitations, pre-syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or
- •3. Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or
- •4. Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure.
- •5. Patient is able to understand the nature of study and has provided written informed consent
- •6. Patient is willing and able to perform all follow up visits at the study site
- •7. Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept
排除标准
- •1. Patients implanted with ICD or pacemaker.
- •2. Patient is pregnant or breast feeding.
- •3. Patient is less than 18 years old.
- •4. Patient is participating in another interventional clinical investigation
- •5. Patient´s life-expectancy is less than 6 months.
研究者
相似试验
已完成
不适用
Investigation of a new implantable cardiac event recorder (BioMonitor 2) in patients with suspected cardiac arrhythmiasCardiac arrhythmiasCardiovascular - Other cardiovascular diseasesACTRN12614001266651BIOTRONIK Australia Pty. Ltd.30
招募中
不适用
Development of Autonomic nervous system Responses for Intensive monitoring and Alert system (ARIA)Diseases of the nervous systemKCT0006205Pusan National University Yangsan Hospital1,000
已完成
不适用
Evaluation of minimal invasive monitoring system for postprandial hyperglycemiaType 2 diabetesJPRN-UMIN000007355Kobe University50
已完成
不适用
Evaluation of minimal invasive monitoring system for postprandial hyperglycemiaType 2 diabetesJPRN-UMIN000003761Osaka Medical Center for Cancer and Cardiovascular Diseases10
已完成
不适用
BIO.MASTER.BioMonitor 2 StudyTachyarrhythmiaAtrial FibrillationSyncopeNCT02565238Biotronik SE & Co. KG92