Sensing Atrial High Rate Episodes With DX System in Implantable Cardioverter Defibrillators Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 8
- 主要终点
- Atrial High Rate Episode
研究概览
简要总结
The primary aim of the "Sensing Atrial High Rate Episodes with DX System in Implantable Cardioverter Defibrillators Trial" (SENSE Trial) is to assess the efficacy of a implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles in detecting atrial high rate episodes.
The study hypothesis is that an ICD system with a lead with dedicated atrial sensing dipoles will have a diagnostic yield comparable to that of a standard dual chamber ICD system and superior to that of a standard single chamber ICD system.
详细描述
The SENSE Trial is designed to study the efficacy of the DX System in detection of atrial high rate episodes (AHREs) in subjects with no prior history of atrial fibrillation. The DX System, or "DX," consists of a Biotronik DX ICD, and the Biotronik Linox Smart S DX lead which is an FDA approved ICD system that incorporates use of an implantable cardioverter-defibrillator (ICD) lead with dedicated atrial sensing dipoles.
The SENSE Trial will be conducted at 8-12 U.S. sites. The lead coordinating site will be at Weill Cornell Medical College. Subjects will be followed for 1 year to assess for the primary endpoints of the trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Fulfills standard indications for ICD implantation
- •Subject or legally authorized representative can provide written authorization per institutional requirements
- •Subject is intended to be implanted with a complete Biotronik DX system (consisting of a Biotronik Ilesto 7 VR-T DX ICD or any future FDA approved Lumax VR-T DX ICD, and the Biotronik Linox Smart S DX lead), or has been implanted with a complete Biotronik DX system no more than 30 days prior to the date of consent
- •Able to comply with Home Monitoring
排除标准
- •Subject has prior diagnosis of atrial fibrillation or atrial flutter
- •Subject has need for atrial pacing
- •Subject unwilling or unable to give informed consent or participate in follow-up
- •Subject is unable to comply with Home Monitoring
- •Subject is pregnant
- •Subject has less than one year estimated life expectancy
- •Subject was implanted with a cardiac device capable of detecting AHREs prior to implantation of the Biotronik DX system
- •Subject was implanted with Biotronik DX system and had an AHRE detection before enrollment
结局指标
主要结局
Atrial High Rate Episode
时间窗: 1 year
Atrial high rate episode \> 30 seconds in duration
次要结局
- Atrial Sensing (DX System)(1 year)