跳至主要内容
临床试验/NCT05884359
NCT05884359招募中不适用

Left Bundle Branch Area Mapping for Conduction System Pacing

Steward St. Elizabeth's Medical Center of Boston, Inc.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Electroanatomical characteristics of the target area for Left Bundle lead implantation

研究概览

简要总结

This study will utilize 3D mapping as a tool to explore electro-anatomical and electrocardiographic characteristics of the Left Bundle Branch Area. We plan on prospectively reviewing the data found from 3D mapping the left bundle branch implantation cases and using the data to improve understanding of electro-anatomical characteristics of this area for a better definition of the implantation target and depth.

详细描述

This is an observational study that will provide the data for further hypothesis generation and confirmation in a larger study. We will define and record electro-anatomical characteristics of the interventricular septum and surrounding areas. Several electro-anatomical characteristics will be measured during the lead placement into the Left Bundle Branch Area. Mapping will be performed with the pacing lead. We will collect electrocardiographic markers of successful and unsuccessful LBBA pacemaker implantation attempts and correlate them with electro-anatomical information.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 30 consecutive patients ages 18 through 88 that undergo Left Bundle Branch area pacemaker implantation.

排除标准

  • Recent MI-less than 3 months
  • Recent Percutaneous Coronary Revascularization-less than 2 weeks
  • Recent Open-Heart Procedures (CABG, Valvular procedures, etc.)-less than 1 month
  • Patients who are acutely ill and unstable, from the investigator's perspective, but require an urgent permanent pacemaker

结局指标

主要结局

Electroanatomical characteristics of the target area for Left Bundle lead implantation

时间窗: Through study completion, an average of 1 year

Electroanatomical metrics

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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