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Safety and Efficacy of His Bundle Pacing Validated by Extracardiac Vagal Nerve Stimulation

NCT04816864 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-20

No results posted yet for this study

Summary

Different studies for extracardiac vagal nerve stimulation (ECANS) have been published and confirmed the influence of the vagus nerve on automaticity and conduction properties of the sinus node, atria, atrioventricular node, as well as the His-Purkinje system (HPS) and ventricles. However, there are limited data on the clinical value and impact of ECANS as well as vagus nerve activity on the parameters of permanent His-bundle (HB) or left bundle branch (LBB) pacing. Moreover, there have been no prospective studies evaluating the feasibility and efficacy of ECANS and the management of ECANS-induced scenarios, such as an exit block, increase in pacing threshold, as well as vagally mediated arrhythmias and conduction abnormalities in patients with physiological conduction system pacing (HB/LBB pacing).

The objective of the HIS-STORY study in humans is to evaluate the clinical value of ECANS in patients with HB/LBB pacing for further development of patient-centered management strategy.

Conditions

  • Permanent His Bundle Pacing
  • Permanent Left Bundle Branch Pacing

Interventions

DIAGNOSTIC_TEST

extracardiac vagal nerve stimulation (ECANS) + EPS

The study intervention will consist of 3 steps, all of which will be performed under general anesthesia: 1. EPS with the measurement of parameters of atrioventricular conduction and programmed atrial and ventricular pacing. 2. ECANS of the right and the left vagus nerve (from the right and left internal jugular vein, respectively; patients will be randomized to start from the right or the left side) performed during: 1) the patient's spontaneous heart rhythm (if present); 2) HB/LBB pacing with permanently programmed impulse parameters; 3) HB/LBB pacing at a pacing threshold of +0.1 V; and 4) 5 minutes after intravenous injection of atropine (0.02-0.04 mg/kg). 3. EPS with the measurement of parameters of atrioventricular conduction and programmed atrial and ventricular pacing.

Sponsors & Collaborators

  • Subcarpathian Center for Cardiovascular Intervention

    collaborator UNKNOWN

  • Mazovian Speciality Hospital

    collaborator UNKNOWN

  • Wroclaw Medical University

    collaborator OTHER

  • 4th Military Clinical Hospital with Polyclinic, Poland

    lead OTHER

Principal Investigators

  • Krystian Josiak, MD, PhD · 4th Military Clinical Hospital with Polyclinic, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-02
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04816864 on ClinicalTrials.gov