NCT01856725已完成不适用
Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- end-systolic volume
研究概览
简要总结
The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule
排除标准
- •Have high ventricular rate (>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
- •Be in NYHA IV functional class
- •Have a recent myocardial infarction within 40 days prior to enrollment
- •Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
- •Have had a recent CVA or TIA within 3 months prior to enrollment
- •Have had intravenous inotropic support in the last 30 days
- •Be less than 18 years of age
- •Be pregnant or planning to become pregnant during the duration of the investigation.
研究组 & 干预措施
MultiPoint Pacing programming based on hemodynamics
Active Comparator
CRT device implant with MultiPoint Pacing
Hemodynamic measurements for CRT device programming
干预措施: Hemodynamic measurements for CRT device programming (Procedure)
MultiPoint Pacing programming based on hemodynamics
Active Comparator
CRT device implant with MultiPoint Pacing
Hemodynamic measurements for CRT device programming
干预措施: CRT device implant with MultiPoint Pacing (Device)
MultiPoint Pacing programming without hemodynamics
Experimental
CRT device implant with MultiPoint Pacing
CRT device programming without hemodynamics
干预措施: CRT device implant with MultiPoint Pacing (Device)
结局指标
主要结局
end-systolic volume
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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