NCT03985527已完成不适用
Transvenous Nerve Stimulation Study (Janus Study)
Respicardia, Inc.3 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2020年1月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Changes in respiration and airway physiology
研究概览
简要总结
The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Subject is at least 18 years old
- •Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator
- •Subject is willing and able to give informed consent
排除标准
- •Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed)
- •Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant)
- •Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
- •Subject has body mass index (BMI) > 40 kg/m2 at the time of implant
- •Subject has had prior neck surgery
- •Previous or currently implanted upper airway stimulation device
- •Subject has had prior oral cavity surgery that may interfere with breathing
- •Subject has significant upper airway-related anatomic anomaly
- •Subject is enrolled in concurrent study that may confound the results of this study
- •Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff
- •Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue
研究组 & 干预措施
Transvenous nerve stimulation
Experimental
干预措施: Transvenous nerve stimulation (Device)
结局指标
主要结局
Changes in respiration and airway physiology
时间窗: During procedure (immediately post-stimulation)
The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant.
次要结局
未报告次要终点
研究者
研究点 (3)
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