Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Infrasound Hemodynography
研究概览
简要总结
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.
详细描述
This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal Sinus Rhythm
- •LV systolic function >53%
排除标准
- •1. Known history of carotid artery disease
- •2. Moderate or greater valvular disease in Group 1
- •3. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)
- •4. Active arrhythmia
- •5. Reduced Ejection Fraction (< 35%) other than Group 4
- •6. Hearing loss
研究组 & 干预措施
Severe aortic stenosis
Patients with echocardiographic evidence of severe aortic stenosis as defined by:
Aortic Vmax ≥4 m/s or mean ΔP ≥40 mmHg AVA ≤1.0 cm2
干预措施: MindMics earbud (Other)
Severe mitral regurgitation
Patients with echocardiographic evidence of severe mitral regurgitation as defined by:
- Central jet MR >40% LA or holosystolic eccentric jet MR
- Vena contracta ≥0.7 cm
- Regurgitant volume ≥60 mL
- Regurgitant fraction ≥50%
- ERO ≥0.40 cm2
- Angiographic grade 3 to 4+
干预措施: MindMics earbud (Other)
Heart Failure with Reduced EF <35%
Patients with echocardiographic evidence of left ventricular ejection fraction of < or = to 35%
干预措施: MindMics earbud (Other)
Pulmonary Hypertension
Patients with echocardiographic evidence of a mean pulmonary artery pressure (mPAP; supine and at rest) >20mmHg
干预措施: MindMics earbud (Other)
Suspected coronary artery disease
Patients with plan to undergo elective left heart diagnostic catheterization for the assessment of coronary artery disease
干预措施: MindMics earbud (Other)
结局指标
主要结局
Infrasound Hemodynography
时间窗: 1 year
Correlation of Infrasound data to hemodynamic parameter(s) and to cardiac time intervals
次要结局
未报告次要终点
研究者
Sanjeev Bhavnani MD
Principal Investigator
Scripps Health