His-Bundle Corrective Pacing in Heart Failure

希氏束矫正性起搏治疗心力衰竭

• 批准号: 10650715
• 负责人: Valentina Kutyifa
• 金额: $ 69.88万
• 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/10650715
• 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); Eligibility Determination; 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; Outcome; Pathologic; Patients; Pattern; Physiological; Quality of life; Randomized; 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; randomized, clinical trials; 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.

希氏束矫正起搏治疗心力衰竭 主要研究者：Valentina Kutyifa，医学博士，哲学博士，Roderick Tung，医学博士 罗切斯特大学医学中心，罗切斯特，纽约州和芝加哥大学，芝加哥，伊利诺伊州 心力衰竭（HF）是一种重要的慢性健康问题，其最常见的原因是可预防的。 住院治疗，与无法支付的医疗保健费用有关。心脏再同步治疗 已经证明，使用除颤器（BIV-CRT）可以改善严重心衰患者的预后， 左心室功能降低，但在一部分患者中， 右束支分支传导阻滞（RBBB）ECG形态。希氏束矫正性起搏 His-BIV是一种新兴技术，对患者特别有帮助。 BIV-CRT不太理想的RBBB ECG模式。然而，数据有限， 与BIV-CRT相比，His-CRT的疗效和作用机制。所以我们 提出一项随机机制临床试验，以前瞻性地评估疗效， His-CRT与BIV-CRT对120例HF患者电和机械损伤的机制 左心室功能严重降低、QRS增宽和RBBB ECG形态。 本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，在6个月时改善了RBBB HF患者的LV射血分数（LVEF）。 我们的次要目的包括评估His-CRT与BIV-CRT相比的获益机制， 评价ECG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。 我们的第三个目标是评估电生理过程的时间发展， 和His-CRT与BIV-CRT的机械性钙化，包括 6时ECG生物标志物、NT-proBNP水平以及功能状态和生活质量的改善， 与BIV-CRT相比，His-CRT植入器械后12个月和24个月。 安全性评估将包括严重不良事件、植入手术相关并发症， 以及随访期间器械和植入电极导线参数的评价。 研究人群将包括120例随机接受His-CRT与BIV-CRT的RBBB HF患者， 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ECG 6、12和24个月时的数据，由中心核心实验室分析。高容量，经验丰富 具有植入器械跟踪记录和研究基础设施的中心将参与， 根据护理标准进行His-CRT和BIV-CRT的植入。