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临床试验/NCT01629160
NCT01629160已完成不适用

Characterization of Normal and Abnormal Ventricular Wall Motion

Abbott Medical Devices1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Feasibility of Ventricular Wall Motion Characterization

研究概览

简要总结

The purpose of this study is to evaluate feasibility of using new technologies to characterize ventricular wall motion in patients indicated for mapping and ablation procedures. Echo will be performed preoperatively and patients will receive a 1-month followup telephone call.

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 in sinus rhythm
  • •Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations
  • •Be undergoing mapping and ablation that requires left heart access for either ventricular tachycardia (VT) or atrial fibrillation (AF) according to HRS (Heart Rhythm Society)/ESC (European Society of Cardiology)/German National guidelines. The patient needs to have at least one of the following indications for left heart mapping and ablation to be included in the study: a) Symptomatic sustained monomorphic VT (SMVT), or b) Frequent PVCs, non-sustained VT, or VT that is presumed to cause ventricular dysfunction, or c) Bundle branch reentrant or interfascicular VTs, or d) Symptomatic AF with indication for ablation per current HRS/ESC/German National guidelines in a patient who is either 1) refractory or intolerant to at least one Class 1 or Class 3 antiarrhythmic medication, or 2) unable/unwilling to take antiarrhythmic drug therapy and chooses ablation as the first line of therapy

排除标准

  • •Have permanent AF
  • •Exhibit Cheyne-Stokes respiration
  • •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
  • •Have had a recent CVA or TIA within 3 months prior to enrollment
  • •Be less than 18 years of age
  • •Be pregnant
  • •Be currently participating in any other clinical investigation

结局指标

主要结局

Feasibility of Ventricular Wall Motion Characterization

时间窗: Mapping and Ablation Procedure

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 (1)

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