Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Ejection fraction
研究概览
简要总结
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Normal AV conduction (SAV<220 ms or PAV<270 MS)
- •Left Bundle Branch Block (defined as > or = to 140 ms (male) or > or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
- •Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
- •Sinus Rhythm at the time of enrollment
排除标准
- •Moderate to severe Aortic Stenosis
- •Moderate to severe Mitral Regurgitation
- •Patient age <18 years old
- •AF burden >15%
- •Severe pulmonary disease requiring supplemental oxygen use
- •System Modification at RRT Generator Changeout
- •AdaptivCRT prior to enrollment
- •Expected patient longevity < 1 year
- •Persistant or chronic atrial fibriliation
- •Women who are pregnant or who plan to become pregnant during the clinical trial
结局指标
主要结局
Ejection fraction
时间窗: 12 Months
Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
NYHA functional class
时间窗: 12 months
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
次要结局
- Left ventricular end systolic volume(12 months)
- Atrial fibrillation burden(12 Months)
- Heart failure hospitalizations(12 months)
- Time to first appropriate therapy for VT and/or VF(12 months)
- Percentage of RV synchronized LV pacing(12 months)