NCT00180531已完成4 期
Monitoring of Arrhythmias and Heart Rate Variability in Patients With Congestive Heart Failure Treated With the Cardiac Resynchronisation Pacemaker Renewal TR2
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 20
- 主要终点
- Occurrence of ventricular arrhythmias
研究概览
简要总结
The objective of this study is to evaluate the prevalence of sustained ventricular and supraventricular rhythm disorders in patients implanted with a CONTAK RENEWAL TR2 ventricular resynchronization therapy (CRT) device
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Moderate or severe chronic heart failure, defined by the presence of NYHA class III or IV symptoms, Intra/interventricular synchronization disorder evaluated by echocardiography and/or Doppler Tissue Imaging (DTI, Yu's method22), Ejection fraction (EF) ≤ 40 %, If previous history of myocardial infarction, MI must be > 60 days from the date of inclusion, Estimated life expectancy > 6 months in the case of concomitant disease, Age ≥ 18 years, Optimal drug treatment of chronic heart failure (according to SFC* recommendations).
排除标准
- •Conventional indication for treatment by implantable defibrillator upon inclusion, Cardiac transplant envisaged within 6 months, Unexplained syncope, MI < 60 days before inclusion, Non compliance to drug treatment for chronic heart failure, Any coronary pathology which may be treated by revascularisation.
结局指标
主要结局
Occurrence of ventricular arrhythmias
Occurrence of supraventricular arrhythmias
次要结局
未报告次要终点
研究者
研究点 (20)
Loading locations...
相似试验
已完成
不适用
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuardCardiac EventNCT00750958Datascope Patient Monitoring287
已完成
不适用
AVAI: Atrial Ventricular Arrythmia IncidenceAtrial FibrillationVentricular TachycardiaNCT00832975Abbott Medical Devices157
进行中（未招募）
不适用
A Prospective Incident Study of Arrhythmias in Hypertrophic CardiomyopathyHypertrophic CardiomyopathyNCT04112290Mayo Clinic260
已完成
不适用
Heart Rate Variability During Auricular Acupressure at Zero Point on the Left Ear in Healthy VolunteersHealthy VolunteersNCT05586698Bui Pham Minh Man114
Unknown
不适用
Reduction or Extension of COnduction Time With Ventricular Electromechanical Remodeling (RECOVER)Heart FailureNCT04397224Samsung Medical Center100