此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Electrically Guided Bachmann's Bundle Pacing: A Lead Placement Strategy With Potential Antiarrhythmic Benefits

2022年3月8日 更新者：Margaret Infeld、University of Vermont

Electrically Guided Bachmann's Bundle Pacing Pilot Study: A Novel Lead Placement Strategy With Potential Antiarrhythmic Benefits

Despite identification of optimal ventricular pacing sites, which not only avoid dyssynchronous activation but can restore ventricular synchrony, optimal atrial pacing sites have not yet been identified. Specialized conduction tracts do not exist in the atria as they do in the ventricle. Activating the atria in a manner that preserves or improves interatrial synchrony may provide clinical benefit based on recent data. Prior site-selective right atrial septal pacing (RAS) pacing studies relied on non-specific fluoroscopic guidance during lead placement. These studies were limited by the lack of an electrogram target and electrical measures of successful atrial resynchronization. The goal of this study is to prospectively evaluate Bachmann's bundle lead placement guided by fluoroscopy and electrical markers (an endocardial electrogram target and paced P-wave criteria) and determine its anti-arrhythmic efficacy compared with right atrial appendage (RAA) pacing. Patients presenting for pacemaker placement with an indication for an atrial lead are randomized to either electrically-guided BB lead placement or RAA lead placement and then followed for 15 months.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Vermont
      • Burlington、Vermont、美国、05401
        • University of Vermont Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Subject is >18 years old
  • Subject is referred for permanent pacemaker implantation with an indication for an atrial lead
  • Subject has either paroxysmal atrial fibrillation or baseline intra-atrial conduction delay (P-wave duration >120ms on a 12-lead ECG)
  • Subject is expected to remain available for standard-of-care pacemaker follow-up visits and study questionnaires

Exclusion Criteria:

  • Subject has permanent atrial fibrillation or is in atrial fibrillation in the pre-operative area prior to the procedure (inability to assess paced P-wave morphology)
  • Subject has pacemaker implantation prior to planned atrioventricular nodal ablation
  • Subject has resting spontaneous sinus rate >85 beats-per-minute
  • Subject has left ventricular ejection fraction <45%
  • Subject is unable or unwilling to complete baseline or follow up quality of life questionnaires
  • Subject is currently enrolled in a potentially confounding trial
  • Subject is pregnant
  • Subject's anticipated life expectancy is less than 1 year

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Bachmann's bundle area pacing
Lead placement in Bachmann's bundle area
程序：Bachmann's bundle lead placement
Atrial lead placement at Bachmann's bundle area
有源比较器：Right atrial appendage pacing
Lead placement in the right atrial appendage
程序：Right atrial appendage lead placement
Atrial lead placement in the right atrial appendage

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Atrial arrhythmia burden from pacemaker counters
大体时间：Over 15 month follow up
Derived from pacemaker counters and expressed as the average percentage of time per day in atrial fibrillation/tachycardia.
Over 15 month follow up

次要结果测量

结果测量
措施说明
大体时间
Change in P-wave duration from sinus P-wave to paced P-wave in Bachmann's bundle and right atrial appendage lead groups
大体时间：At implant
At implant
Atrial lead procedure time
大体时间：At implant
At implant
Atrial lead fluoroscopy time
大体时间：At implant
At implant
Atrial lead complications
大体时间：Over 15 month follow up
Over 15 month follow up
Atrial lead capture threshold (Volts)
大体时间：Over 15 month follow up
Over 15 month follow up
Atrial lead sensing threshold (millivolts)
大体时间：Over 15 month follow up
Over 15 month follow up
Atrial lead impedance threshold (Ohms)
大体时间：Over 15 month follow up
Over 15 month follow up
Atrial Fibrillation Severity Scale Version 2.0
大体时间：Over 15 month follow up

Change in quality of life. The Atrial Fibrillation Severity Scale (AFSS) is composed of 19 items investigating four domains:

  1. AF burden (comprised of AF frequency + AF duration + AF severity): score range is 3-10, higher score = greater burden
  2. Health care utilization: score range is 0-7 for each question, higher score = more utilization
  3. Symptoms: score range is 0-35, higher score = greater symptom severity
  4. Global well-being: score range is 1-10, higher score = better quality of life
Over 15 month follow up
EQ-5D-3L survey (*EQ-5D-3L is the name of the instrument and is not an acronym)
大体时间：Over 15 month follow up
Change in quality of life. The EQ-5D-3L is a standardized instrument to assess generic health-related quality of life and contains questions on five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. For each of the five dimension, respondents are offered three response categories (no problems, some problems, extreme problems), leading to 243 possible health states. These health states are then converted into index based values (utilities) ranging from 0 to 1 by applying a valuation algorithm. The EQ-5D instrument includes a visual analogue scale (VAS), on which the patient is asked to score his/her current health state between 0 (worst imaginable health state) and 100 (best imaginable health state).
Over 15 month follow up
Hospitalization or urgent outpatient visit for atrial fibrillation
大体时间：Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
Hospitalization or urgent outpatient visit for heart failure
大体时间：Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
Cerebrovascular accident
大体时间：Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
Atrial Fibrillation Ablation
大体时间：Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker
New start or up-titration of medications for the primary diagnosis of atrial fibrillation
大体时间：Within 15 months follow-up post pacemaker
Within 15 months follow-up post pacemaker

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Vermont

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年5月28日

初级完成 (预期的)

2023年6月1日

研究完成 (预期的)

2023年6月1日

研究注册日期

首次提交

2021年11月15日

首先提交符合 QC 标准的

2021年11月27日

首次发布 (实际的)

2021年12月10日

研究记录更新

最后更新发布 (实际的)

2022年3月9日

上次提交的符合 QC 标准的更新

2022年3月8日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 00001532

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

De-identified data upon reasonable request

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅