Study to Compare the Cardiac Resynchronization Therapy (CRT) Response Rate in a Heart Failure (HF) Population With an Equal Distribution of Men and Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 494
- 试验地点
- 2
- 主要终点
- Left Ventricular Ejection Fraction (LVEF) changes at 12 month Follow Up (FU)
研究概览
简要总结
BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response rate in a Heart Failure (HF) population with an equal distribution of men and women. Different clinical variables will be collected (QRSd, Left Bundle Brunch Block (LBBB), HF etiology...) and compared in order to demonstrate that women may respond even better than men.
详细描述
Prospective, non-randomized, international, open, multicenter study. Patients that comply with the inclusion and exclusion criteria will be implanted with a BIOTRONIK CRT system.
The primary objective is to study the magnitude of CRT response measured as function of increase in Left Ventricular Ejection Fraction (LVEF) in order to demonstrate a superior CRT response in women.
The Secondary main objectives are:
- To study changes in major clinical variables during a 12M FU period in men and women
- To study how Left Ventricular End Diastolic Volume (LVEDV) and Left Ventricular End Systolic Volume (LVESV) change in men and women with CRT response
- To study CRT responders and value if there are significant gender differences at baseline with regards of presence of inter/intra ventricular dyssynchrony, HF etiology (ischemic versus non-ischemic cardiomyopathy), QRS morphology (LBBB vs. RBBB) and QRSd
- Observational assessment of how key baseline clinical variables are related to the patient's CRT response, to create a possible "gender specific" response model.
- Study the relationship between QRSd (amount of dyssynchrony) and CRT response in men and women
There are no study specific requirements for the implantation procedure of the CRT device; implantation will be performed according to the routine hospital's practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Indication for a "De Novo" implantation of a CRT device according to ESC Guidelines
- •Understand the nature of the procedure
- •Give written informed consent
排除标准
- •CRT Device replacements
- •CRT upgrades
- •Permanent / Persistent Atrial Fibrillation
- •Age< 18 years
- •Pregnant and breastfeeding women
- •Subjects with irreversible brain damage from pre existing cerebral disease
- •Subjects with acutely de compensated heart failure
- •NYHA Class IV Heart Failure
- •Heart transplantation six months prior to the enrolment or expected within next 3 months.
- •Cardiac surgery 3 months prior to the enrolment or planned within next 3 months.
- •Have a life expectancy of less than 12 months
结局指标
主要结局
Left Ventricular Ejection Fraction (LVEF) changes at 12 month Follow Up (FU)
时间窗: Baseline, 6 and 12 month
To study the magnitude of Cardiac Resynchronization Therapy (CRT) response in women measured as a function of improvement in LVEF at 12moth FU in order to demonstrate that CRT response in women is better than men.
次要结局
- Left Ventricular End Diastolic Volume (LVEDV)(Baseline, 6 and 12 month)
- 12 lead electrocardiogram (ECG)(Baseline)
- Quality Of Life test (QOL score)(Baseline, 6 and 12 month Follow Up)
- NYHA class(Baseline, 6 and 12 month Follow Up)
- Patient's global self-assessment score(2, 6 and 12 month Follow Up)
- 6 minute walk test(Baseline, 6 and 12 month Follow Up)
- Left Ventricular End Systolic Volume (LVESV)(Baseline, 6 and 12 month)