NCT01609985已完成不适用
Cutaneous Heart Sounds Data Collection During CRT Optimization Study
Medtronic Cardiac Rhythm and Heart Failure5 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2012年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 5
- 主要终点
- Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors.
研究概览
简要总结
The Cutaneous Heart Sounds Data Collection During CRT Optimization study is an acute, prospective, non-randomized multi-center feasibility clinical trial. The purpose of this clinical trial is to collect data to assist in the testing and finalization of a hemodynamic sensor-based cardiac resynchronization therapy (CRT) optimization scheme.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have been implanted with a Medtronic market approved CRT-D device (Concerto®, Concerto® II, Maximo® II, Consulta®, Protecta™, or Protecta™ XT) within two years
- •Subject must be 18 years of age or older
- •Subject or his/her legally authorized representative has signed and dated the study specific informed consent form ("Consent Form")
- •Subject is willing and able to comply with protocol requirements
排除标准
- •Subject with atrial tachyarrhythmia or frequent atrial or ventricular ectopy
- •Subject is post mitral or aortic valve repair or replacement
- •Subject is participating in other research studies that many confound the results of this study
- •Subject is pregnant or in fertile age without secure birth control
- •Subject has dementia
- •Subject is unwilling to comply with protocol requirements
- •Subject has a device and lead system with fractured leads
- •Subject cannot undergo an echocardiograph procedure, or is contraindicated to undergo such a procedure
结局指标
主要结局
Collection of simultaneous cardiac signals representing heart sounds and CRT-D electrogram (EGM) vectors.
时间窗: A two hour office visit within two years of CRT-Defibrillator (D) and lead system implant
The cardiac signals collected by the modified Virtuoso® ICD and implanted CRT-D EGM vectors will be used to determine how to improve and finalize a prototyped hemodynamic sensor-based CRT optimization scheme.
次要结局
- Comparison of modified Virtuoso® Implantable Cardiac Defibrillator (ICD) heart sounds and CRT-D electrogram (EGM) vectors(A two hour office visit within two years of CRT-D and lead system implant)
- Determine if modified Virtuoso® ICD recorded heart sounds and CRT-D recorded EGM are able to detect phrenic nerve stimulation (PNS)(A two hour office visit within two years of CRT-D and lead system implant)
研究者
研究点 (5)
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