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临床试验/NCT02547207
NCT02547207终止不适用

MultiPoint Pacing Mapping Study

Abbott Medical Devices4 个研究点 分布在 3 个国家目标入组 7 人开始时间: 2015年12月最近更新:
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

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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