NCT01733368已完成不适用
Observational Study to Evaluate the Management of Patients Resynchronized With the QuartetTM LV Quadripolar Lead
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Safety Outcomes in CRT Responders and Non-Responders
研究概览
简要总结
Optimization and evolution of the patient will be evaluated over 6 months after the implant.
详细描述
Patient will be enrolled into the study after Informed Consent signature and CRT-D+quadripolar (QuartetTM) LV lead.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 implanted CRT-D device and a QuartetTM quadripolar lead by St. Jude Medical in the left ventricle.
- •Patient with an echocardiographic study performed during 1 month prior to the implant and in whom End Systolic Volume of the Left Ventricle (LVESV) has been measured
- •Patients who have granted their informed consent.
- •Patients above 18 years.
排除标准
- •Patients that have been previously resynchronized.
- •Patients with aortic stenosis or aortic valve prosthesis
- •Patients who are or may potentially be pregnant.
- •Patients with a life expectancy <12 months.
- •Patients who cannot attend the monitoring visits established by the protocol.
结局指标
主要结局
Safety Outcomes in CRT Responders and Non-Responders
时间窗: 6 months after implant
* Mortality rate, * Rate of cardiovascular hospitalizations and for any cause or * Combined endpoint (death and all-cause hospitalization)
Number of Responder Patients (Structural Remodelling)
时间窗: 6 months after implant
Structural remodelling is defined as a reduction \>15% in Left Ventricle End Systolic Volume (LVESV), measured 6 months after implant.
次要结局
- Number of Responder Patients With Non-conventional Left Ventricular Pacing Vector(6 months after implant)
- Number of Responder Patients With Conventional Left Ventricular Pacing Vector(6 months after implant)
研究者
研究点 (1)
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