His Pacing Feasibility and Cardiac Electrical Activation

Overview

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.

Full Title of Study: “His Pacing in Patients Without Need for Cardiac Resynchronization – Clinical Feasibility and Cardiac Electrical Activation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2024

Detailed Description

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.

Interventions

  • Device: His Pacing
    • The patients 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.

Arms, Groups and Cohorts

  • Experimental: His Pacing
    • Implant of a supplementary His pacing lead in addition to a traditional RV pacing lead.

Clinical Trial Outcome Measures

Primary Measures

  • Rate of chronic His pacing success
    • Time Frame: Evaluated at 1 year follow up
    • Chronic His capture with clinically acceptable pacing threshold (<=3.5V)

Secondary Measures

  • Rate of perioperative His pacing success
    • Time Frame: The implant procedure duration i.e. incision to skin closure
    • Perioperative his capture with clinically acceptable pacing threshold (<=3.5V)
  • QRS duration (ms)
    • Time Frame: Implantation to 1 year follow up
    • Comparing His pacing and RV pacing
  • Changes in left ventricular echocardiographic two-dimensional strain dyssynchrony parameters
    • Time Frame: Implant to 1 year follow up
    • Comparing left ventricular mechanical dyssynchrony during His pacing and RV pacing using echocardiographic two-dimensional longitudinal strain
  • Changes in regional right and left ventricular electrical activation delay
    • Time Frame: Implant to 1 year follow up
    • Comparing electrical activation pattern during His pacing and RV pacing using non-invasive electroanatomical mapping. This is achieved using software that merges data from a 12-lead electrocardiogram (ECG), chest wall three-dimensional picture of ECG lead positions, and a cardiac computed tomography scan.

Participating in This Clinical Trial

Inclusion Criteria

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

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aalborg University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Margrethe Thoegersen, Medical Doctor – Aalborg University Hospital
  • Overall Official(s)
    • Sam Riahi, MD PhD, Study Director, Aalborg University Hospital
    • Peter S√łgaard, MD DMSc, Study Director, Aalborg University Hospital
  • Overall Contact(s)
    • Anna M Th√łgersen, MD DMSc, +4597664427, anmat@rn.dk

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