NCT02547207终止不适用
MultiPoint Pacing Mapping Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings
研究概览
简要总结
The purpose of this study is to characterize left ventricular acute hemodynamic and electrical responses during cardiac resynchronization therapy (CRT) with different Multipoint Pacing (MPP) settings, and assess the relationship between electrical activation patterns and hemodynamic measurements during these pacing settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 scheduled to undergo or have received within the past 30 days an implant of a SJM (St. Jude Medical) MPP CRT-D system with approved standard indication by ESC (European Society of Cardiology) / EHRA (European Heart Rhythm Association) 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
- •Be in sinus rhythm
排除标准
- •Complete AV (atrioventricular) block
- •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 7 months
- •Have had a recent CVA (cerebrovascular accident) or TIA (transient ischemic attack) 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 plan to become pregnant over the next 7 months
- •Have significant peripheral vascular disease
- •Have LV thrombus
- •Significant aortic valve disease or replacement
- •Mitral valvular disease
- •Contraindicated for Gadolinium contrast agent
结局指标
主要结局
Left ventricular (LV) dP/dt Max (maximum change in pressure over time) in mmHg/s during different pacing settings
时间窗: up to 30 days post-implant
次要结局
未报告次要终点
研究者
研究点 (4)
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