NCT03141606Unknown不适用
Left Atrial Volume as Predictor for Arrhythmic Events and CRT Response
Ospedale Borgo Trento - Verona2 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2016年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- CRT Predictor Index
研究概览
简要总结
Left atrial volume role for CRT response and for arrhythmic events (VT/VF/AT/AF) onset
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 with left ventricular ejection fraction ≤ 35%, II, III or IV NYHA Class, even if optimal medical therapy.
- •Patients with standard indication to CRT according current guideline, sinus rhythm at implantation, LBBB and QRS duration >= 120 ms
- •Patients who will undergo to a new CRT-defibrillator system implantation
- •Patients who are able to understand and sign the informed consent
- •Patients who are able to attend all required follow-up visits at the study centerfor 24 months
排除标准
- •Age < 18 years
- •Women who are pregnant or who are planning to become pregnant
- •Patients with permanent Atrial Fibrillation or persistent Atrial Fibrillation in the 90 days preceding the implantation
- •Patients with organic mitral valve disease
- •Patients with prosthetic heart valves
- •Patients who will undergo to upgrading from other devices (PM or ICD) to CRT, heart transplantation, patients with CRT devices
结局指标
主要结局
CRT Predictor Index
时间窗: 6 months
Identification of left atrial index predicting CRT response
Cardiac remodelling
时间窗: 6 months
Evaluation of function and volume of left atrium (by means of echocardiographic measures) in terms of cardiac remodelling (at least 15% reduction in LVESV).
次要结局
- Cardiac remodelling(6 months)
- Clinical benefit(12 months)
- Ventricular arrhythmias(24 months)
- Atrial arrhythmias(24 months)
研究者
Dr. Giovanni Morani
MD
Ospedale Borgo Trento - Verona
研究点 (2)
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