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

Not Applicable

Recruiting

• Conditions: Permanent His Bundle Pacing; Permanent Left Bundle Branch Pacing
• Interventions: Diagnostic Test: extracardiac vagal nerve stimulation (ECANS) + EPS

• Registration Number: NCT04816864
• Lead Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland

Brief 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.

Detailed Description

This is a multicenter, prospective, open-label, randomized, interventional study enrolling patients with indications for permanent cardiac pacing according to the current European Society of Cardiology Guidelines on Cardiac Pacing. All participants will undergo permanent pacemaker implantation for HB or LBB pacing. Subsequently, an invasive electrophysiological study (EPS) and ECANS will be performed. The 2 x 2 randomisation will be performed, i.e. right vs left side superior ECANS and blinded for operator ultrasonography guided effective vs ineffective inferior vagal nerve stimulation). The randomisation will prove the feasibility and efficacy of superior ECANS and feasibility, efficacy, and reproducibility of ultrasonography guided inferior ECANS. All the measured parameters as well as demographic and clinical data will be recorded in the study database. Patients with an exit block or an increase in a pacing threshold of an HB/LBB electrode will be further managed by electrophysiologists from the research group. The management will be based on clinical assessment and patient's decision and may involve pacemaker reprogramming, pacemaker upgrade with a back-up pacing electrode implantation, or cardio-neuro-ablation.

Study Timeline

• Study Start: 2021-01-02
• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-25
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• signed informed consent form
• effective and stable HB or LBB pacing
• sinus rhythm during the intervention procedure

Exclusion Criteria

• contraindications to invasive EPS
• contraindications to general anesthesia
• contraindications to atropine administration (e.g., glaucoma)
• persistent atrial fibrillation or atrial flutter
• pregnancy
• diseases that may cause autonomic system neuropathy
• use of medications that may affect the parasympathetic system
• a history of cardiac surgery
• a history of ablation due to arrhythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECANS started from the right vagus nerve	extracardiac vagal nerve stimulation (ECANS) + EPS	superior ECANS and ultrasonography guided inferior ECANS
ECANS started from the left vagus nerve	extracardiac vagal nerve stimulation (ECANS) + EPS	superior ECANS and ultrasonography guided inferior ECANS

Primary Outcome Measures

Name	Time	Method
Loss of HB/LBB capture or significant increase in pacing threshold	0-12 months after HB/LBB pacemaker implantation	significant increase in pacing threshold = above the permanently programmed impulse amplitude of HB/LBB electrode induced by ECANS

Secondary Outcome Measures

Name	Time	Method
A nonsignificant increase in pacing threshold	0-12 months after HB/LBB pacemaker implantation	below the permanently programmed impulse amplitude of HB/LBB electrode induced by ECANS
Prolongation of the stimulus-QRS interval during HB/LBB pacing induced by ECANS	0-12 months after HB/LBB pacemaker implantation

Trial Locations

Locations (3)

Subcarpathian Center for Cardiovascular Intervention; 🇵🇱 Sanok, Podkarpackie, Poland

4th Military Hospital, Cardiology Department; 🇵🇱 Wroclaw, Dolnoslaskie, Poland

Mazovian Speciality Hospital, Cardiology Department; 🇵🇱 Radom, Mazowieckie, Poland