BIO-LIBRA Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 49
- 主要终点
- Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
研究概览
简要总结
The purpose of this registry is to prospectively assess outcomes of device-treated ventricular tachyarrhythmias and all-cause mortality in non-ischemic cardiomyopathy patients indicated for ICD or CRT-D implantation for the primary prevention of sudden cardiac death. Differences in outcomes will be evaluated by sex and by device type.
详细描述
The BIO-LIBRA Study will gather information about women and men with non-ischemic cardiomyopathy who are treated with implanted ICD and CRT-D devices from many locations across the United States. The BIO-LIBRA Study will look at the results of treatment in women and men enrollees. The two primary goals are: 1) to learn if there are differences in treatment response based on the patient's sex; and 2) to learn if there are differences in patient outcomes based on device type.
There is a special focus on women in the BIO-LIBRA Study. Usually, only about 25% of people in prior device studies have been women. Yet heart disease is the number-one cause of death for women - one in three deaths each year. The BIO-LIBRA Study would like to have a more balanced study which includes more women than in prior studies. The goal is for at least 40% of the people participating in the study to be women.
The study will observe up to 1,000 women and men over a three-year period following the device implant. Utilizing information collected at annual doctor visits and scheduled transmission reports from the implanted device in between these visits, the BIO-LIBRA Study will be able to evaluate some of the common risks of non-ischemic cardiomyopathy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient meets current guideline-defined indication for de novo, primary prevention ICD or CRT-D implantation
- •Patient has non-ischemic etiology of cardiomyopathy
- •Patient is successfully implanted with a de novo BIOTRONIK ICD or CRT-D device and commercially available leads no more than 30 days prior to consent or is scheduled for de novo implantation of a BIOTRONIK ICD or CRT-D device no more than 30 days post consent
- •Patient is able to understand the nature of the study and provide informed consent
- •Patient is available for standard of care follow-up visits to occur at least yearly at the study site for to the expected 3 years of follow-up
- •Patient is willing to utilize BIOTRONIK Home Monitoring® via CardioMessenger
- •Patient age is greater than or equal to 18 years
排除标准
- •Patient meets secondary prevention ICD indication
- •Patient has ischemic etiology of cardiomyopathy
- •Patient is enrolled in any investigational cardiac device or drug trial that might significantly affect the studied outcomes
- •Patient is expected to receive heart transplantation or ventricular assist device within 1 year
- •Patient life expectancy is less than 1 year
- •Patient reports pregnancy at the time of consent
结局指标
主要结局
Evaluation of the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events
时间窗: 3 years post-implant
Evaluate the combined risk of all-cause mortality and treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events by sex and by implanted device type
次要结局
- Rate of all-cause mortality(3 years post-implant)
- Rate of treated ventricular tachycardia (VT) or ventricular fibrillation (VF) events(3 years post-implant)
- Rate of cardiac death(3 years post-implant)
- Comparison of the Seattle Proportional Risk Model (SPRM) predicted incidence of sudden death to the observed incidence of death(3 years post-implant)
- Rate of sudden cardiac death(3 years post-implant)