Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- LivaNova
- 试验地点
- 5
- 主要终点
- The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).
研究概览
简要总结
Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.
详细描述
The primary objective is to estimate the change in severity of Sleep Breathing Disorders (SBD) in patients with or without reverse remodeling, in de-novo or upgrade implants, after 6 month follow-up.
The main secondary objective is to assess the prevalence, type and evolution of the SBD, co-morbidities and major adverse cardiac events in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.
Predictors of the clinical outcomes will be investigated.
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
- •Patient successfully* implanted (de-novo implant, upgrade or replacement) with a LivaNova CRT-P device, according to the latest applicable CRT guidelines and IFU
- •Signed and dated informed consent
- •The subject will be available for postoperative follow-up beyond one year
排除标准
- •Chronic hypercapnic respiratory failure (under oxygen therapy - that could confound the results of this study)
- •Already included in another clinical study that could confound the results of this study
- •Not available to attend routine follow-up visits
- •Not able to understand the aim of the study and its procedures
- •Minor age (according to local regulation)
- •Drug / alcohol addiction or abuse
- •Known pregnancy
- •Under guardianship
研究组 & 干预措施
Single arm study
only 1 arm - no comparison nor randomization in this study
干预措施: Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire (Other)
结局指标
主要结局
The change in severity of SBD (by means of AHI as determined by PG), in the responders to CRT (reverse remodeling, delta LVESV=>15%) compared to the non-responders, at 6-month follow-up after implant (de-novo or upgrade).
时间窗: 6 months
次要结局
- The main secondary objective is to assess the type of the SBD in each subgroup of HF patients (based on the etiology), up to 12 months follow-up period.(12 months)