QUARTET LEAD AND RESYNCHRONIZATION THERAPY OPTIONS To Investigate the Stimulatory Possibilities Offered by the Different Configurations Available for the Quartet Lead and Their Effect on Haemodynamic and Clinical Response.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.
研究概览
简要总结
The purpose of this Clinical Trial is to determine the percentage of patients whose hemodynamic response improves with the different configurations offered by the new Quartet® left ventricular lead, as a result of its four electrodes, with respect to the configurations offered by a standard bipolar lead.
Furthermore, the optimal stimulation configuration will be determined from a comparison with traditional configurations.
详细描述
This is a prospective, non-randomised, multi-centre, national, interventional clinical trial of a medical device.
This trial involves two visits: one at the beginning of the study, which will be undertaken in the seven days following implant, and another visit at 6 months after enrollment. It is recommended that the enrollment visit is undertaken as soon as possible after implantation, although the time window allows the timing to be adapted to each centre's standard practice. Resynchronization therapy in those patients suitable for participation in this trial is expected to begin once this enrollment visit has been completed.
Once data collection at enrollment visit has been completed, final device programming will be based on each investigator's criteria and will be undertaken following the standard practice of each centre.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients with a Cardiac resynchronization Therapy Defibrillator device (CRT-D) and a Quartet® quadripolar electrode from St Jude Medical (used in "Single Site Pacing" mode) implanted in the left ventricle.
- •Patients who have provided written informed consent
- •Patients who are in sinus rhythm.
- •Patients older than 18 years of age.
排除标准
- •Patients in atrial fibrillation at the time of the echocardiographic study of the enrollment visit.
- •Patients with valvular disease.
- •Patients in functional class New York Heart Association (NYHA) IV
- •Patients for whom echocardiography images suitable for determining the cardiac output cannot be obtained.
- •Patients whose device has been changed/upgraded.
- •Pregnant patients.
- •Patients who do not fulfill all the inclusion criteria.
- •Patients who are unable to provide written informed consent
研究组 & 干预措施
CRT therapy
Cardiac Resynchronization Therapy Defibrillator (CRT-D)
干预措施: Cardiac Resynchronization Therapy Defibrillator (Device)
结局指标
主要结局
Number of Patients Whose Cardiac Output (CO) Value in Acute, as Measured Echocardiographically, Improves With the Different Stimulation Vectors Offered by the Quartet® Left Ventricular Electrode.
时间窗: Enrollment visit (in the seven days after implantation of the device)
次要结局
- Capture Threshold(6 months post-implant)
- Percent Difference Between the Best CO From Non-traditional Vectors and Best CO From Traditional Vectors(At enrollment)
- Cardiac Output (CO) With Different Configurations at Enrollment(Enrollment visit (in the seven days after implantation of the device))
- Number of Vectors With Phrenic Nerve Stimulation (PNS)(At 6 months)
- Number of Patients With PNS in All Vectors(At 6 months)
- Number of Patients With PNS in All Vectors, That Could be Avoided With a Non-traditional Vector(At 6 months)