Responders and Quadripolar LV Lead in CRT
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months
研究概览
简要总结
The purpose of this study is to observe the evolution of the CRTD system with left quadripolar lead, in terms of electrical parameters in all pacing configurations and to evaluate the impact on the clinical outcome.
详细描述
Cardiac resynchronization therapy (CRT) is limited by a high proportion of non-responders.
Pacing activation from proximal area with a left quadripolar lead might improve the depolarization pattern.
To explore the effect of CRT pacing on cardiac activity, the investigators will enroll approximately 180 patients who already underwent CRT-D implantation with a quadripolar LV lead.
After implant, as clinical practice, the device will be programmed with distal LV pacing configuration, after 6 months in patient non-responders to CRT therapy the pacing configuration will be changed (proximal configuration).
After 12 months in patients non-responders will be changed the pacing configuration again, choosing, if it is possible, a multi point pacing (pacing activation from multiple separated left ventricular (LV) sites).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Be in NYHA II, III or IV functional class with approved standard indication by ESC/EHRA Guidelines
- •Successful quadripolar LV lead implant
排除标准
- •Less than 18 years of age
- •Epicardial Lead
- •Life expectancy < 12 months
- •Pregnant or are planning to become pregnant during the duration of the investigation
结局指标
主要结局
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 6 months
时间窗: 6-Months
Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 12 months
时间窗: 12-Months
次要结局
- Percentage of patients presenting improving in Heart Failure Clinical Composite and reverse remodeling after 18 months(18 months)
研究者
Antonello Vado
MD
Ospedale Santa Croce-Carle Cuneo