Validation of Signal Waveforms in a Consumer-based Wristwatch Prototype Device During Standard Cardiac Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography
研究概览
简要总结
The iBeat Study is a single-center, prospective, unblinded validation of the photoplethysmography (PPG) and tissue oximetry (TO) signal waveforms recorded from a wrist-based sensor devices.
详细描述
The goal of the proposed research is to validate PPG and TO signal waveforms recorded from a wist-based sensor device, which is worn on one or both arms, during catheter ablation, device interrogation, and defibrillation threshold testing (DFT). It is a non-invasive procedure that will include placing a wrist-based sensor on subjects who consent participate. Data collected from routine clinical care devices used during these procedures (catheter ablations, device interrogations, and DFTs) will confirm data collected from the iBeat wristwatch.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years and ≤ 85 years
- •Able to understand and give informed consent.
- •Subject is presenting for the following planned procedures:
- •3.1 Group A (25 subjects): Subjects presenting for catheter ablation for cardiac arrhythmias (e.g. atrial fibrillation, supraventricular tachycardia, or ventricular tachycardia) 3.2 Group B (25 subjects): Subjects judged based on the clinical evaluation of high, greater than 75%, atrial pacing or ventricular pacing burden or known pacing dependence with planned device interrogation for: 1) pacemaker (single or dual chamber), 2) implantable cardioverter-defibrillator (single or dual chamber), or 3) cardiac resynchronization therapy with or without defibrillator (single or dual chamber plus left ventricular pacing).
- •3.3 Group C (5 subjects): Subjects for clinically indicated defibrillation threshold testing (DFT) (with a transvenous or subcutaneous ICD lead system)
排除标准
- •Age < 21 years and > 85 years
- •Unable to or refuse to give written informed consent
- •Unwilling or unable to wear the smartwatch device on at least one wrist
- •Uncorrected severe aortic stenosis or subaortic stenosis (including hypertrophic cardiomyopathy) with outflow tract obstruction > 50 mm
- •New York Heart Association Class IV Heart Failure
结局指标
主要结局
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using photoplethysmography
时间窗: Immediate
Detect hemodynamic significant arrhythmia using changes in photoplethysmography \[PPG\] as measured using a wrist-watch.
Detect hemodynamic significant (e.g. Ventricular tachycardia, ventircular fibrillatio, supra ventricular tachycardia with fast ventricular rate, etc) arrhythmias using tissue oxygenation
时间窗: Immediate
Detect hemodynamic significant arrhythmia using changes in tissue oxygenation as measured using a wrist-watch.
次要结局
- Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in photoplethysmography(Immediate)
- Detect benign arrhythmia (e.g. sinus tachycardia, atrial flutter, atrial fibrillation supra-ventricular tachycardia) using changes in tissue oxygenation(Immediate)