NCT01058551已完成不适用
Incidence of New Onset Atrial Fibrillation in Patients With Severe Obstructive Sleep Apnea: The Reveal XT-SA Study
Dr. Adrian Baranchuk2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2011年6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
- 31
- 试验地点
- 2
- 主要终点
- To determine the incidence of new onset AF in patient's with severe OSA
研究概览
简要总结
Single site study: The goal of the study is to determine the incidence of new onset atrial fibrillation (AF) in patients with severe obstructive sleep apnea (OSA) syndrome through the use of a Medtronic Reveal XT implantable Loop recorder (ILR). The ILR device is approved for use in Canada, for the assessment of atrial fibrillation.
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
- •Patients with severe OSA defined as Apnea Hypopnea Index (AHI) >
- •Age > 18 years.
排除标准
- •Previous history of clinical AF defined as documented lone, paroxysmal, persistent or permanent, according to standard definitions.
- •Patient with anticipated requirement of MRI.
- •Patient with well-know allergy to any component of the Medtronic Reveal XT.
- •Patients with implantable cardiac rhythm device [pacemakers or internal cardiac device (ICDs)].
- •Women of child bearing potential.
- •Unable or unwilling to provide written informed consent.
- •Unable or unwilling to complete the study follow-up schedule (eg. intention to leave the Kingston area over the next 3 years.
- •Previously enrolled in this trial.
- •Enrolled in another study that would confound the results of this trial.
- •Documented history of heart failure
- •Diagnosed with severe obstructive sleep apnea greater than 1 year from screening date
结局指标
主要结局
To determine the incidence of new onset AF in patient's with severe OSA
时间窗: 36 months
次要结局
- To determine the impact of continuous positive airway pressure (CPAP) treatment in patients with new onset of AF in patients with severe OSA. (post hoc analysis)(36 months)
研究者
Dr. Adrian Baranchuk
MD
Queen's University
研究点 (2)
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