NCT04613544Unknown不适用
A Prospective, Open Label, Multi-Center, Pilot Study to Assess Safety, Efficacy and Usability of Application for Atrial Fibrillation Vocal Marker
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Safety Assessment
研究概览
简要总结
Voice Assist Arrhythmia Monitoring (VAAM) is an application running on smartphones and/or landline phones that performs vocal tests for the monitoring of abnormalities in the heart rhythm.
详细描述
Following ICF signature and process and eligibility confirmation, subject will have a training session to assure correct application use. The subjects will be asked to pronounce few vowels 3 times a day to be evaluated by the application analysis algorithm at the patient natural environment.
At the same time, a single lead ECG system will be recorded synchronously ECG for reference with the use of dedicated recording device
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male at age of ≥18 years and above.
- •All AF types Or Medical history of Cryptogenic stroke.
- •Ability and willingness to sign an informed consent form
排除标准
- •Subjects with implanted cardiac defibrillators or pacemakers neurostimulators and/or body worn medical devices such as insulin pumps.
- •Subjects diagnosed with any heart arrhythmias other than A-Fib, except for PVC.
- •Patient who underwent cardioversion or ablation in the last year and is in stable sinus rhythm.
- •Women who are pregnant or breastfeeding (women of child-bearing potential must provide a declaration stating that they are not pregnant)
- •Tremor or Parkinson's disease
- •Current hoarseness
- •Barriers for communication and lack of capability to execute the handlings required for this study.
- •Subjects who are currently enrolled in another clinical investigation. Parallel Enrollment to a non-interventional study is permitted.
结局指标
主要结局
Safety Assessment
时间窗: 6 weeks
related Adverse device effect
次要结局
- Usability(6 weeks)
- Effectivness(6 wweeks)
研究者
研究点 (2)
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