Optimization of New CRT Recipients: Subjects Randomized to ECG Belt or Echocardiographic Optimization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Echocardiographic assessment of LV size
研究概览
简要总结
Cardiac resynchronization therapy (CRT) has been a valuable intervention for patients with systolic heart failure for over 15 years. Despite years of research, there is a still a 25-40% non-responder rate depending on the outcomes measured. CRT optimization is a term used to describe the act of individualizing the therapy (CRT programming) for an individual patient. This is not often performed, but when it is, echocardiography is utilized. Recent work of body surface mapping using a novel system called the ECG Belt has shown a relationship between measures of electrical dyssynchrony and acute and chronic heart pumping function. This study will compare outcomes of patients randomized to either echocardiographic or ECG Belt optimization of CRT devices.
详细描述
This is a prospective randomized study designed to determine whether cardiac resynchronization therapy (CRT) device programming guided by the ECG Belt (Medtronic, PLC) improves echocardiographic and functional outcomes in heart failure (HF) patients. The population will include patients treated with CRT for standard indications (not implanted for the sole purposes of this study). The study will focus enrollment on patients who do not have baseline characteristics predicting the best CRT response. Therefore the study will not enroll patients having non-ischemic HF etiology, left bundle branch (LBBB) morphology, and QRSd > 150 ms or those previously RV paced.
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
- Single (Outcomes Assessor)
盲法说明
Individual analyzing echocardiograms (primary outcome) will not know randomization of the subject.
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent for participation in the study
- •Age ≥18 years
- •Received a first-time CRT device for standard clinical indication (can be upgraded from non-CRT pacemaker or defibrillator if ventricular pacing < 10%)
- •Adequate echocardiographic images for EF & LVESV determination
排除标准
- •Unhealed open wounds on the torso and/or a history of documented severe allergic reactions from ECG electrode gel
- •Enrollment in a concurrent study that could confound the results of this study
- •Pregnant or could become pregnant within the 6 month follow-up period
- •Non-ischemic cardiomyopathy, LBBB morphology, and QRSd > 150 ms
- •Dysrhythmia (AF or PVCs) that will likely result in aggregate ventricular pacing < 90% over the 6 month follow-up period
结局指标
主要结局
Echocardiographic assessment of LV size
时间窗: 6 months post optimization
Change in left ventricular end-systolic volume
Echocardiographic assessment of LV function
时间窗: 6 months post optimization
Change in ejection fraction
次要结局
未报告次要终点
研究者
Alan J. Bank, MD
Medical Director of Research - United Heart & Vascular Clinic
Allina Health System