Atrio-Ventricular Delay Optimization in Patients Implanted With a Cardiac Resynchronization Device Using Echocardiography Versus the SonR Signal: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Optimal blood flow method
研究概览
简要总结
The purpose of this study is to evaluate an external device (SonR sensor) that is capable of detecting sounds created by the heart (SonR signal). Based on the sounds created by the heart and recorded by the SonR sensor, optimal timing settings for the cardiac resynchronization therapy defibrillator (CRT-D) device may be determined. The investigators will then compare the timing settings suggested by SonR to the settings suggested from the echocardiogram. The objective of this study is to determine if differences exist between these different methods of timing the contractions of the top and bottom chambers of the heart and if the SonR signal is able to produce results similar to those of an echocardiogram.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with any current Food and Drug Administration (FDA) approved CRT- D device and leads for 30 days or patients indicated for AV optimization
- •≥18 years of age
- •Ability and willingness to provide written informed consent and HIPAA authorization
排除标准
- •Chronic Atrial Fibrillation
- •Heart Failure decompensation event within two weeks of enrollment
- •Hypertrophic Obstructive Cardiomyopathy
- •Patient currently enrolled in another ongoing clinical trial
- •Pregnancy
- •Less than 18 years of age
- •Inability or unwillingness to provide written informed consent and HIPAA authorization
研究组 & 干预措施
All Patients
All patients will have an echocardiogram and SonR sensor readings completed.
干预措施: Echocardiogram/SonR (Other)
结局指标
主要结局
Optimal blood flow method
时间窗: 3 months
To determine the best method of timing the contractions of the top and bottom chambers of the heart by using echocardiography versus using signals of the external SonR sensor.
次要结局
未报告次要终点