Multi-lead ECG to Effectively Optimize Resynchronization Devices: New CRT Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in left ventricular size
研究概览
简要总结
Cardiac resynchronization therapy (CRT), or atrial-synchronized biventricular (BiV) pacing, is an FDA-approved device therapy option for heart failure (HF) patients with reduced left ventricular ejection fraction and electrical dyssynchrony. A traditional CRT device has pacing leads implanted within the right atrium (RA), the right ventricle (RV), and within a coronary vein overlying the lateral or posterior left ventricle (LV). Within the past decade, various multi-center randomized controlled trials have reported improved quality of life, aerobic exercise capacity, LV systolic function and structure, as well as decreased hospitalization rates and mortality among patients with HF. Despite improvements in CRT technology with multipoint pacing, quadripolar leads, and adaptive pacing algorithms, approximately 30% of patients do not clinically benefit and are considered non-responders. This study looks to optimize new CRT device recipients using information obtained from standard ECG machines.
详细描述
This is a prospective, randomized study designed to evaluate if CRT device optimization, guided by electrocardiography, improves echocardiographic and clinical outcomes among HF patients with a CRT device implanted for standard indications. All patients will have measurement of electrocardiograms at a range of device settings. Patients will be randomized in a 1:1 ratio to either the active comparator arm (standard CRT programming), or the experimental arm (CRT device programmed by the information obtained by ECGs). Standard CRT programming used in this study is simultaneous biventricular (BiV) pacing with a fixed atrioventricular delay. At 6 months, control patients who were initially randomized to standard programming will have programming changed based on the ECG optimization information. Patients will be blinded to randomization. Change of LV size and function will be performed prior to randomization, and again ~6 and ~12 months following CRT implant in both subgroups.
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, Outcomes Assessor)
盲法说明
Patients blinded to which study group they randomized and how their CRT device is programmed. Individuals (readers) who perform echocardiographic measurements blinded to patient randomization and CRT settings.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (or their legal guardian) must be willing to provide informed consent and sign a data privacy authorization (HIPAA) form
- •Age greater than or equal 18 years
- •Pre-CRT EF less than or equal 40%
- •Patients will be receiving or have received a first-time CRT device for standard clinical indications within ~2 months of study enrollment
- •Adequate echocardiographic images for LV EF and LV ESV determination
- •On optimal medical therapy
排除标准
- •Patients who are pregnant or may become pregnant
- •Patient has a history of severe allergic reactions from ECG gel/ electrode adhesives
- •Patient has a His Bundle pacing lead
- •Patient has right bundle branch block (RBBB)
- •Patient is enrolled in concurrent research study that would potentially confound the results of this study
- •Premature ventricular contraction (PVC) burden greater than or equal to 10%
研究组 & 干预措施
Standard CRT Programming, then ECG CRT Optimization
The control arm patients will have standard CRT programming for the first 6 months, and then will be reprogrammed based on the ECG CRT optimization information for the following 6 months
干预措施: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony (Device)
ECG CRT Optimization
The experimental arm patients will have CRT device reprogrammed based on the ECG CRT optimization information for 12 months.
干预措施: Reprogramming of CRT Device Settings to Optimal Electrical Synchrony (Device)
结局指标
主要结局
Change in left ventricular size
时间窗: 6 months
Change in left ventricular end-systolic volume (LVESV), measured by echocardiogram, in patients in the experimental arm vs active comparator arm
次要结局
- Change in left ventricular size(6 months)
- Change in left ventricular function(6 months)
研究者
Alan J. Bank, MD
Medical Director of Research - United Heart & Vascular Clinic
Allina Health System