Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,285
- 试验地点
- 42
- 主要终点
- All-Cause Mortality
研究概览
简要总结
The "EUropean Comparative Effectiveness Research to assess the use of primary prophylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD)" is a modular research project to study the effectiveness of prophylactic ICDs in a prospective study, a retrospective registry, and meta-analyses of existing evidence on the subject.
详细描述
The prospective study part is an observational, prospective multi-centre study which aims to enrol 2500 patients with ischemic or dilated cardiomyopathy and primary prophylactic ICD indication for reduced left ventricular ejection fraction (LVEF) according to current guidelines. According to the treating physician's decision and preference which is independent from study participation, patients are recruited into one of two groups: patients directly prior to first ICD implantation (ICD Group), or patients who are not considered for prophylactic ICD treatment by the physician or are considered but refuse ICD treatment (Control Group). Patients will undergo simple 12-lead electrocardiogram (ECG) and Holter ECG diagnostics at baseline as well as genetic biobanking at entry to the study. All patients will be subsequently followed for at least 1 year and up to 4 years. Co-primary endpoints are all-cause mortality and appropriate ICD shocks.
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
- •Ischemic or dilated cardiomyopathy and recommendation for primary prophylactic ICD treatment following current international treatment guidelines
- •Written informed consent
- •If ICD implantation is planned, enrollment and study baseline testing needs to be completed before de-novo ICD implantation
排除标准
- •Permanent atrial fibrillation or atrial fibrillation at baseline in case more than 15% of such patients at a given time have been enrolled
- •Indication for secondary prophylactic ICD treatment
- •Indication or candidate for cardiac resynchronization therapy
- •AV block II°-III° at resting heart rates
- •Implanted pacemaker
- •Unstable cardiac disease such as decompensated heart failure (NYHA functional class IV) or acute coronary syndrome
- •Participation in other clinical trials which exclude enrolment in other trials
结局指标
主要结局
All-Cause Mortality
时间窗: one to five years
Co-Primary Endpoint
First Appropriate ICD Shock
时间窗: one to five years
Co-Primary Endpoint
次要结局
- Time to First Inappropriate Shock(one to five years)
- Sudden Cardiac Death(one to five years)
- Cardiac Death(one to five years)
- Non-Cardiac Death(one to five years)
- Arrhythmogenic Syncope(one to five years)
- Resuscitation(one to five years)
- Any ICD Shock(one to five years)
- Quality of Life(one to five years)
- Device Revision / Device Replacement(one to five years)
- Atrial Fibrillation(one to five years)
- Costs and Cost-Effectiveness(one to five years)
研究者
Markus Zabel
Associate Professor of Medicine
University Medical Center Goettingen