His-Bundle Corrective Pacing in Heart Failure

希氏束起搏治疗心力衰竭 Pi：瓦伦蒂娜·库蒂法，医学博士，罗德里克·董，医学博士 纽约罗切斯特大学医学中心和伊利诺伊州芝加哥大学 心力衰竭(HF)是一个重要的慢性健康问题，是可预防的最普遍的原因 住院，与难以承受的医疗保健费用有关。心脏再同步化治疗 使用除颤器(BIV-CRT)可以改善严重心力衰竭患者的预后 左心功能降低，然而，它在一组患者中显示的益处较小 伴有右束支传导阻滞(RBBB)的心电图形态。希氏束起搏用于心脏矫正性起搏 再同步(HIS-BIV)是一项新兴的技术，对患者可能特别有帮助 对于BIV-CRT不太理想的RBBB心电图型。然而，数据仅限于 His-CRT与BIV-CRT的疗效和作用机制的比较。因此，我们 建议进行一项随机的机械性临床试验，以前瞻性地评估其疗效和 His-CRT与BIV-CRT对120 HF电和机械再同步化的作用机制 患者左心功能严重减退，QRS波宽，RBBB心电信号形态改变。 这项试验的主要目的是前瞻性评估HIS-CRT是否更有效 与BIV-CRT相比，合并RBBB的心衰患者6个月后左室射血分数(LVEF)明显改善。 我们的次要目标是评估HIS-CRT与BIV-CRT的受益机制 评价心电生物标记物、血清生物标记物和超声心动图生物标记物的变化。 我们的第三个目标是评估电的生物过程的时间发展 His-CRT与BIV-CRT的机械再同步化，包括时间变化 心电生物标志物，NT-proBNP水平，以及6岁时功能状态和生活质量的改善， 术后12个月、24个月His-CRT组与BIV-CRT组比较。 安全评估将包括严重不良事件、与植入程序相关的并发症、 并在随访期间评估装置和植入导联的参数。 研究人群将包括120名患有RBBB的心衰患者，他们被随机分为HIS-CRT组和BIV-CRT组。 1：1的比例。我们将收集基线和6个月时的超声心动图数据，以及连续的心电 6个月、12个月和24个月的数据，由中央核心实验室分析。量大、经验丰富 植入了设备跟踪记录和研究基础设施的中心将参与其中， His-CRT和BIV-CRT的植入按护理标准进行。

His-Bundle Corrective Pacing in Heart Failure PI: Valentina Kutyifa, MD, PhD, Roderick Tung, MD University of Rochester Medical Center, Rochester, NY, and University of Chicago, Chicago, IL Heart failure (HF) is a significant chronic health issue with the most prevalent cause of preventable hospitalizations, linked to insurmountable health care costs. Cardiac resynchronization therapy with a defibrillator (BIV-CRT) has been shown to improve outcomes of HF patients with severely reduced left ventricular function, however it was shown to be less beneficial in a subset of patients with right bundle branch block (RBBB) ECG morphology. His-bundle corrective pacing for cardiac resynchronization (His-BIV) is an emerging technology that could be especially helpful in patients with RBBB ECG pattern in whom BIV-CRT is less optimal. However, data are limited on the efficacy and on the mechanism of action of His-CRT as compared to BIV-CRT. Therefore, we propose a randomized mechanistic clinical trial to prospectively evaluate the efficacy and mechanisms of His-CRT vs. BIV-CRT on electrical and mechanical resynchronization in 120 HF patients with severely reduced left ventricular function, wide QRS, and RBBB ECG morphology. The primary aim of this trial is to prospectively evaluate whether His-CRT is more effective improving LV ejection fraction (LVEF) at 6 months than BIV-CRT in HF patients with RBBB. Our secondary aim includes assessing the mechanism of benefit with His-CRT vs. BIV-CRT by evaluating changes in ECG biomarkers, serum biomarkers, and echocardiography biomarkers. Our tertiary aim is to evaluate the temporal development of the biological processes of electrical and mechanical resynchronization with His-CRT vs. BIV-CRT, including temporal changes of ECG biomarkers, NT-proBNP levels, and improvement in functional status and quality of life at 6, 12, and 24 months following device implantation with His-CRT as compared to BIV-CRT. Safety assessment will include serious adverse events, implant procedure-related complications, and evaluation of device and implanted lead parameters during follow-up. Study population will include 120 HF patients with RBBB randomized to His-CRT vs. BIV-CRT in a 1:1 ratio. We will be collecting echocardiography data at baseline and 6-month, and serial ECG data at 6, 12, and 24 months, analyzed by central core laboratories. High-volume, experienced centers with implanted device track records and research infrastructure will participate, with implantation of His-CRT and BIV-CRT performed according to standard of care.