His-Bundle Corrective Pacing in Heart Failure

希氏束矫正性起搏治疗心力衰竭

• 批准号: 10341653
• 负责人: Valentina Kutyifa
• 金额: $ 72.81万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10341653
• 关键词: Aleurites; Biological Markers; Biological Process; Bundle-Branch Block; Cessation of life; Chicago; Chronic; Clinical; Clinical Trials; Data; Defibrillators; Devices; Doctor of Philosophy; EFRAC; Echocardiography; Electrocardiogram; Electrophysiology (science); Emerging Technologies; Evaluation; Event; Health; Health Care Costs; Heart; Heart failure; Hospitalization; Implant; Implantation procedure; Laboratories; Lead; Left; Left Ventricular Ejection Fraction; Left Ventricular Function; Length of Stay; Link; Mechanics; Medical center; Morphology; Mosses; Multi-Institutional Clinical Trial; Outcome; Pathologic; Patients; Pattern; Physiological; Quality of life; Randomized; Randomized Clinical Trials; Records; Research Infrastructure; Serious Adverse Event; Serum; System; Time; Universities; Ventricular; arm; biological development; cardiac pacing; cardiac resynchronization therapy; cost; efficacy evaluation; experience; follow-up; functional status; implantable device; implantation; improved; improved outcome; innovative technologies; mortality; new technology; novel; patient subsets; persistent symptom; pro-brain natriuretic peptide (1-76); prospective; response; safety assessment; standard of care; study population; treatment arm; treatment strategy

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.

他的束纠正心力衰竭 PI：瓦伦蒂娜·库蒂法（Valentina Kutyifa），医学博士，博士 纽约州罗切斯特的罗切斯特大学医学中心和伊利诺伊州芝加哥的芝加哥大学 心力衰竭（HF）是一个重大的慢性健康问题，最普遍的原因是可预防的 住院，与无法克服的医疗保健费用有关。心脏重新同步疗法 借助除颤器（BIV-CRT）已显示可改善严重的HF患者的预后 左心室功能降低，但是显示出一部分患者的好处 具有右束分支块（RBBB）ECG形态。他的捆绑矫正步调为心脏 重新同步（HIS-BIV）是一种新兴技术，可能对患者特别有用 具有RBBB ECG模式，其中BIV-CRT不太最佳。但是，数据受到限制 与BIV-CRT相比，HIS-CRT的作用机理的功效和作用机理。因此，我们 提出一项随机机械临床试验，以预期评估功效和 HIS-CRT与BIV-CRT的机理在120 hf中的电气和机械重新同步 严重降低左心室功能，宽QRS和RBBB ECG形态的患者。 该试验的主要目的是预期评估HIS-CRT是否更有效 HF患者的HF患者比BIV-CRT在6个月时改善LV射血分数（LVEF）。 我们的次要目的包括评估使用HIS-CRT与BIV-CRT的利益机制 评估心电图生物标志物，血清生物标志物和超声心动图生物标志物的变化。 我们的三级目的是评估电气生物学过程的时间发展 与His-CRT与BIV-CRT的机械重新同步，包括时间变化 ECG生物标志物，NT-ProBNP水平以及6点的功能状况和生活质量的改善， 与BIV-CRT相比，用His-CRT植入设备后的12个和24个月。 安全评估将包括严重的不良事件，植入程序相关并发症， 在随访期间对设备和植入铅参数的评估。 研究人群将包括120例RBBB的HF患者与His-CRT与BIV-CRT随机分配 1：1的比率。我们将在基线和6个月内收集超声心动图数据，以及串行ECG 由中央核心实验室分析的6、12和24个月的数据。大量，经验丰富 具有植入设备记录和研究基础架构的中心将参加 根据护理标准进行HIS-CRT和BIV-CRT的植入。