Screening for Sleep-disordered Breathing in Routine Cardiology Practice: Validation of the Apnea + Hypopnea Detection by an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy-defibrillator (CRT-D) With Impedance-based Respiration Sensor (ApneaScanTM)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 5
- 主要终点
- Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
研究概览
简要总结
The purpose of the study is to compare, three months after implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D), the apnea-hypopnea index (AHI) obtained from conventional in-lab NPSG/NPG (AHIPSG) with similar indices obtained from autoscoring algorithms of the ApneaScan™, an implantable impedance-based respiration sensor (AHIAS).
详细描述
This is a prospective, multi center, phase-IV with blinded analysis and central reading of polysomnography trial.
The study is performed in patients with a standard CRT-D or Implantable Cardioverter Defibrillator (ICD) devices indication. A total of 160 subjects will be recruited in France. The study duration is 03 months for each subject.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male and female aged > 18 years old
- •Current ICD or CRT-D device-based guidelines indication (for primo-implantation)
- •patients with optimal recommended medical therapy
- •Patient willing and able of undergoing the device implant procedure
- •Patient willing and able of undergoing the LATITUDE® NXT Patient Management system procedure
- •Patient willing and able to complete the requirements of the study including the signature of the Informed Consent after full explanation of the study by the investigator prior to participation.
排除标准
- •Obstructive lung disease as defined by a FEV1/FVC less than 70%
- •Obesity hypoventilation syndrome
- •Treated sleep disorders breathing
- •Cardiac surgery scheduled or strong likelihood of cardiac surgery 4 months after enrollment
- •Life expectancy less than 1 year
- •Inability to complete overnight PSG as defined by the protocol
- •Patient who are or suspected to be pregnant and or plan to become pregnant
- •Patient protected by the Law, under guardianship or curators
- •Concomitant participation in an interventional biomedical research trial
结局指标
主要结局
Apnea-hypopnea index obtained from polysomnography or polygraphy and from autoscoring algorithms of the ApneaScan™ implantable impedance respiration sensor
时间窗: Prior the ICD or CRT-D implantation and up to 3 months
次要结局
- Malignant arrhythmogenic events detected daily by the ICD / CRT-D (AF, ES, supraventricular tachycardia, sustained and non sustained ventricular tachycardia, VF) and night by night AHI assessed by the ApneascanTM(baseline and up to 3 months)
- Weekly weight readings automatically and wirelessly sent to the LATITUDE(C)(Baseline and Up to 3 months)
- Apnea and Hypopnea index measured 3 months after ICR or CRT-D implantation compared to the Apnea and Hypopnea index measured at baseline by the polysomnography or polygraphy(Prior the ICD or CRT-D implantation and up to 3 months)