NCT00148967已完成4 期
Inhibition of Unnecessary RV Pacing With AV Search Hysteresis in ICDs
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,535
- 主要终点
- Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.
研究概览
简要总结
INTRINSIC RV is a two-armed randomized trial that will compare the effects of innovative dual-chamber pacing with AV Search Hysteresis to standard VVI among ICD patients.
详细描述
The purpose of study is to assess whether AVSH will provide benefits of a dual-chamber ICD without the deleterious effects of unnecessary RV pacing. This study will aim to demonstrate that DDDR-AVSH is equal to VVI with respect to mortality and HF hospitalizations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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 who meet VITALITY™AVT® ICD indications
- •Patients who sign and date a Patient Informed Consent prior to device implant
- •Patients who remain in the clinical care of the enrolling physician
排除标准
- •Patients with current indication for CRT-D
- •Patients who previously had a pacemaker, ICD or CRT-D
- •Patients with chronic AF
- •Patients whose life expectancy is <12 months due to other medical conditions
- •Patients who are expected to receive a heart transplant during the duration of the study
- •Patients with epicardial pacing leads
- •Patients who have CABG, PCI, cardiac or other arrhythmia surgery planned but not yet performed
- •Patients with or who are likely to receive a tricuspid or other valve prosthesis
- •Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
- •Patients who are younger than 18 years of age
- •Patients who are pregnant
- •Patients who are mentally incompetent and cannot give Patient Informed Consent or participate in the study
结局指标
主要结局
Demonstrate that DDDR-AVSH is as effective as VVI with respect to the composite endpoint of death or heart failure hospitalizations.
次要结局
- The following variables will be compared between patients who are randomized to either DDDR-AVSH or VVI:
- The prevalence of atrial fibrillation, Changes in medication dosage, including beta-blocker, anti-arrhythmic and coumadin medications, Programming changes, Quality of life
研究者
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