NCT03087084Unknown不适用
RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)
Medtronic BRC6 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2018年8月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure
研究概览
简要总结
The purpose of this prospective, non-randomized, single-arm, research study is to evaluate the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac device impedance in subjects with heart failure.
In addition, to assess the feasibility of extracting respiratory rate from device EGM under various conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have heart failure and be undergoing implant of a new or replacement/upgrade Medtronic dual-chamber Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator device for approved indications;
- •Subject must be implanted with an right ventricle lead that supports bipolar pacing and sensing (i.e. a true bipolar defibrillation lead);
- •Subject must receive a light conscious sedation or no sedation where breathing maneuvers can be performed and evaluated during the implant;
- •Subject must be willing to provide Informed Consent for their participation in the study;
- •Subject must be ≥ 18 years of age.
排除标准
- •Subjects who are unable or unwilling to voluntarily participate in any visit required by the study and to provide consent;
- •Subject has congenital heart disease;
- •Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure;
- •Subject has unstable coronary artery disease;
- •Subject requires cardiac pacing at rest for rate support;
- •Subject presents any concomitant conditions which in the opinion of the investigator would not allow a proper execution of the respiratory exercises as per protocol;
- •Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study;
- •Subject is pregnant or breast feeding;
- •Subject is legally incompetent;
- •Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager.
研究组 & 干预措施
Cardiac Pacing and Impedance Measurement system
Experimental
干预措施: Cardiac Pacing and Impedance Measurement system (Device)
结局指标
主要结局
Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure
时间窗: Implant
Impedance-derived respiratory rate during different breathing patterns
次要结局
- Assess the feasibility of extracting respiratory rate from EGM under various conditions(Implant and 2 months follow-up)
研究者
研究点 (6)
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