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临床试验/NCT04739553
NCT04739553Unknown不适用

His Pacing in Patients Without Need for Cardiac Resynchronization - Clinical Feasibility and Cardiac Electrical Activation

Aalborg University Hospital0 个研究点目标入组 25 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
主要终点
Rate of chronic His pacing success

研究概览

简要总结

This study will examine the clinical feasibility of His pacing in patients with expected high demand for ventricular pacing and no established indication for cardiac resynchronization therapy. Secondarily, examine differences in electrical and mechanical cardiac activation between traditional pacing and His pacing.

详细描述

After being informed about the study and potential risks, all eligible patients giving written consent will be included. The study is a clinical single-center interventional study. The patients (n = 25) need to have an expected high demand for ventricular pacing and no established class I indication for cardiac resynchronization therapy. They will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port. Postoperatively, the baseline examinations will include: transthoracic echocardiography, 12-lead ECG with a 3D photography of the chest wall to document ECG electrode location, and a contrast-enhanced cardiac CT scan. The echocardiography and ECG will be performed during traditional right ventricular pacing only and His pacing only. His pacing will be used as the permanent programming of choice if feasible during follow up. The CT scan is used for documenting the final positions of the pacing leads and to create a patient-specific 3D model of the cardiac electrical activation using a software which enables merging of a CT scan and ECG and a CT chest photography. During follow up (1-3 and 12 months), transthoracic echocardiography, 12-lead ECG and 3D chest photography are repeated for assessment of mechanical and electrical function during pacing. The performance of all implanted pacing lead will be evaluated at each follow up visit.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Permanent pacemaker indication with expected high demand of right ventricular pacing (>40%) and left ventricular ejection fraction >40%.

排除标准

  • No class I indication for CRT pacemaker (HRS 2018 Pacing Guidelines)
  • Hemodynamically unstable patients
  • Severely reduced kidney function
  • Former serious adverse reactions to contrast media
  • Pregnant or lactating
  • Severe psychiatric disorder which can compromise compliance with protocol

结局指标

主要结局

Rate of chronic His pacing success

时间窗: Evaluated at 1 year follow up

Chronic His capture with clinically acceptable pacing threshold (\<=3.5V)

次要结局

  • Rate of perioperative His pacing success(The implant procedure duration i.e. incision to skin closure)
  • QRS duration (ms)(Implantation to 1 year follow up)
  • Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters(Implant to 1 year follow up)
  • Changes in regional right and left ventricular electrical activation delay(Implant to 1 year follow up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Margrethe Thoegersen

Medical Doctor

Aalborg University Hospital

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