Clinical trial NCT04816864: Safety and Efficacy of His Bundle Pacing Validated by Extracardiac Vagal Nerve Stimulation
Official title: Safety and Efficacy of HIs Bundle Pacing Validated by electrophySiological STudy, autonOmic Tests and extRacardiac Vagal Nerve Stimulation (HIS-STORY)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Permanent His Bundle Pacing
Permanent Left Bundle Branch Pacing
Keywords: His bundle pacing
left bundle branch pacing
extracardiac vagal nerve stimulation
Lead sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
Sponsor class: OTHER
Collaborators: name: Subcarpathian Center for Cardiovascular Intervention
name: Mazovian Speciality Hospital
name: Wroclaw Medical University
First posted: 2021-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Loss of HB/LBB capture or significant increase in pacing threshold
timeFrame: 0-12 months after HB/LBB pacemaker implantation
Secondary outcomes:
measure: A nonsignificant increase in pacing threshold
timeFrame: 0-12 months after HB/LBB pacemaker implantation
measure: Prolongation of the stimulus-QRS interval during HB/LBB pacing induced by ECANS
timeFrame: 0-12 months after HB/LBB pacemaker implantation
Other outcomes:
measure: Any arrhythmia induced by ECANS
timeFrame: 0-12 months after HB/LBB pacemaker implantation
Locations:
city: Wroclaw
country: Poland
facility: 4th Military Hospital, Cardiology Department
state: Dolnoslaskie
city: Radom
country: Poland
facility: Mazovian Speciality Hospital, Cardiology Department
state: Mazowieckie
city: Sanok
country: Poland
facility: Subcarpathian Center for Cardiovascular Intervention
state: Podkarpackie
Study officials:
affiliation: 4th Military Clinical Hospital with Polyclinic, Poland
name: Krystian Josiak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.
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citation: Burri H, Jastrzebski M, Vijayaraman P. Electrocardiographic Analysis for His Bundle Pacing at Implantation and Follow-Up. JACC Clin Electrophysiol. 2020 Jul;6(7):883-900. doi: 10.1016/j.jacep.2020.03.005.
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citation: Stec S, Dobaj L, Sledz A, Stepien-Walek AM, Ton V, Sledz J. Cardioneuroablation for management of cardioinhibitory vasovagal syncope and pacemaker complications. HeartRhythm Case Rep. 2020 May 11;6(8):531-534. doi: 10.1016/j.hrcr.2020.04.021. eCollection 2020 Aug. No abstract available.