NCT03089281已完成不适用
Strategic Management to Optimize Response To Cardiac Resynchronization Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 699
- 试验地点
- 142
- 主要终点
- CRT Response
研究概览
简要总结
The primary objective is to evaluate the benefit of the SmartDelay™ algorithm in patients with a prolonged RV-LV interval.
详细描述
The primary hypothesis of SMART CRT is that among cardiac resynchronization therapy defibrillator (CRT-D) patients with prolonged inrerventricular delay between the RV and LV leads, CRT with atrioventricular optimization (AVO) will result in greater reverse LV remodeling compared with CRT programmed at nominal settings (120 ms).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be indicated to receive a de novo quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) in conjunction with an ACUITY X4 LV lead. This includes subjects who are indicated to receive an upgrade to a BSC X4 CRT-D from a previously implanted device.
- •In order to achieve a homogenous population for the study, qualifying subjects are those with heart failure who meet BSC US indications for use defined as those subjects who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
- •Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
- •Left bundle branch block (LBBB) with QRS duration ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
- •Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws
- •Subject is willing and capable of providing informed consent
- •Subject is willing and capable of complying with visits and procedures as defined by this protocol
排除标准
- •Subjects with documented permanent complete AV block
- •Subjects with permanent or chronic atrial fibrillation (AF) or in AF at the time of enrollment
- •Subjects who have previously received cardiac resynchronization therapy with pacing in the left ventricle
- •Subjects on the active heart transplant list or who has or is to receive ventricular assist device (VAD)
- •Life expectancy shorter than 12 months due to any medical condition (e.g., cancer, uremia, liver failure, etc...)
- •Subject with a known or suspected sensitivity to dexamethasone acetate (DXA)
- •Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
- •Women of childbearing potential who are or plan to become pregnant during the course of the trial
- •Subjects currently requiring dialysis
结局指标
主要结局
CRT Response
时间窗: Pre-Implant baseline to 6 months
Comparing cardiac resynchronization therapy (CRT) response rates between AV Delay programming schemes defined by SmartDelay or a Fixed AV Delay of 120ms. A negative change in LVESV is considered an improvement; CRT response is defined by a change in Left Ventricular End Systolic Volume (LVESV) \< -15% at 6 months compared to pre-implant baseline.
次要结局
- Change in Left Ventricular End Systolic Volume (Absolute Change)(Implant to 6 Months)
- Change in Left Ventricular End Systolic Volume (Relative Change)(Implant to 6 Months)
- Change in Left Ventricular Ejection Fraction (Absolute Change)(Implant to 6 Months)
- Change in Left Ventricular Ejection Fraction (Relative Change)(Implant to 6 Months)
- Clinical Composite Score (CCS)(Implant to 6 Months)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(Implant to 6 Months)
研究者
研究点 (142)
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