NCT01917266已完成不适用
Evaluation of Left Ventricular (LV) Lead Positioning Using MediGuide
适应症
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
- Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation
研究概览
简要总结
The purpose of this study is to evaluate Cardiac Resynchronization Therapy(CRT) response in subjects with concordant versus discordant left ventricular (LV) lead position as compared to the site of latest mechanical activation.
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 implant of a Cardiac Resynchronization Therapy (CRT) system with approved standard indication per accepted guidelines as a new implant or an upgrade from an existing Implantable Cardioverter Defibrillator (ICD) or pacemaker with no prior left ventricular lead placement
- •Be in sinus rhythm at the time of enrollment
- •Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigational Plan described evaluations
排除标准
- •Have persistent or permanent atrial fibrillation
- •Be in New York Heart Association (NYHA) IV functional class
- •Have prior left ventricular (LV) lead implant
- •Be pacemaker-dependent
- •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 Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months prior to enrollment
- •Have had intravenous inotropic support in the last 30 days
- •Exhibit Cheyne-Stokes respiration
- •Be less than 18 years of age
- •Be pregnant or planning to become pregnant during the duration of the investigation
- •Be currently participating in any other clinical investigation
结局指标
主要结局
Percent of patients with the left ventricle (LV) lead implanted at the site of latest mechanical activation
时间窗: This outcome measure will be assessed after an off-line analysis immediately after implant
次要结局
- Response to Cardiac Resynchronization Therapy (CRT) as defined by percent change in end-systolic volume (ESV) at 6-month follow-up relative to baseline.(6 months after implant)
研究者
研究点 (1)
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