NCT02064751已完成不适用
Noninvasive Hemodynamics for MultiPoint(TM) Pacing Programming 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
- 4
- 主要终点
- Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
研究概览
简要总结
The purpose of this study is to evaluate noninvasive hemodynamics with MultiPoint™ Pacing (MPP) and biventricular (BiV) pacing under various vector combinations and paced delays in patients receiving cardiac resynchronization therapy (CRT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Be scheduled to undergo de novo implant of a St. Jude Medical CRT-D system
- •Be in NYHA II or III functional class 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 persistent or permanent atrial fibrillation
- •Have a recent myocardial infarction within 40 days prior to enrollment
- •Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 12 months
- •Have had a recent Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 3 months prior to enrollment
- •Have had intravenous inotropic support in the last 30 days
- •Be scheduled or considered for heart transplantation over the next 12 months
- •Be less than 18 years of age
- •Be pregnant or plan to become pregnant over the next 12 months
研究组 & 干预措施
MultiPoint Pacing
Experimental
CRT with MultiPoint Pacing
干预措施: CRT with MultiPoint Pacing (Device)
MultiPoint Pacing
Experimental
CRT with MultiPoint Pacing
干预措施: Hemodynamic measurements for CRT device programming (Procedure)
结局指标
主要结局
Systolic blood pressure changes in hemodynamics during BiV pacing and MPP
时间窗: up to 6-months
次要结局
- echocardiographic changes to MPP programming guided by noninvasive hemodynamic measurements(6 months)
研究者
研究点 (4)
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