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

NCT04816864 | Unknown

• 1 other identifier: 4thMilitaryH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Permanent His Bundle Pacing; Permanent Left Bundle Branch Pacing

Keywords

His bundle pacing; left bundle branch pacing; extracardiac vagal nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Loss of HB/LBB capture or significant increase in pacing threshold

  significant increase in pacing threshold = above the permanently programmed impulse amplitude of HB/LBB electrode induced by ECANS

  0-12 months after HB/LBB pacemaker implantation

Secondary Outcomes (2)

• A nonsignificant increase in pacing threshold

  0-12 months after HB/LBB pacemaker implantation

• Prolongation of the stimulus-QRS interval during HB/LBB pacing induced by ECANS

  0-12 months after HB/LBB pacemaker implantation

Other Outcomes (1)

• Any arrhythmia induced by ECANS

  0-12 months after HB/LBB pacemaker implantation

Study Arms (2)

ECANS started from the right vagus nerve

ACTIVE COMPARATOR

superior ECANS and ultrasonography guided inferior ECANS

Diagnostic Test: extracardiac vagal nerve stimulation (ECANS) + EPS

ECANS started from the left vagus nerve

ACTIVE COMPARATOR

superior ECANS and ultrasonography guided inferior ECANS

Diagnostic Test: extracardiac vagal nerve stimulation (ECANS) + EPS

Interventions

extracardiac vagal nerve stimulation (ECANS) + EPS DIAGNOSTIC_TEST

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.

ECANS started from the left vagus nerve; ECANS started from the right vagus nerve

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland: lead
• Subcarpathian Center for Cardiovascular Intervention: collaborator
• Mazovian Speciality Hospital: collaborator
• Wroclaw Medical University: collaborator

Study Sites (3)

4th Military Hospital, Cardiology Department

Wroclaw, Lower Silesian Voivodeship, 50-981, Poland

RECRUITING

Mazovian Speciality Hospital, Cardiology Department

Radom, Masovian Voivodeship, 26-617, Poland

RECRUITING

Subcarpathian Center for Cardiovascular Intervention

Sanok, Podkarpackie Voivodeship, 38-500, Poland

RECRUITING

Related Publications (10)

• 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.

  PMID: 29535066 RESULT

• Kronborg MB, Mortensen PT, Poulsen SH, Gerdes JC, Jensen HK, Nielsen JC. His or para-His pacing preserves left ventricular function in atrioventricular block: a double-blind, randomized, crossover study. Europace. 2014 Aug;16(8):1189-96. doi: 10.1093/europace/euu011. Epub 2014 Feb 7.

  PMID: 24509688 RESULT

• Dandamudi G, Vijayaraman P. How to perform permanent His bundle pacing in routine clinical practice. Heart Rhythm. 2016 Jun;13(6):1362-6. doi: 10.1016/j.hrthm.2016.03.040. Epub 2016 Mar 22. No abstract available.

  PMID: 27016475 RESULT

• Josiak K, Nowak K, Fuglewicz A, Jagielski D, Banasiak W, Ponikowski P. Does right ventricular pacing increase the risk of ventricular arrhythmias in patients with an implantable cardioverter-defibrillator? Kardiol Pol. 2014;72(4):381-4. doi: 10.5603/KP.2014.0073. No abstract available.

  PMID: 24733700 RESULT

• Sharma PS, Dandamudi G, Naperkowski A, Oren JW, Storm RH, Ellenbogen KA, Vijayaraman P. Permanent His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice. Heart Rhythm. 2015 Feb;12(2):305-12. doi: 10.1016/j.hrthm.2014.10.021. Epub 2014 Oct 22.

  PMID: 25446158 RESULT

• 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.

  PMID: 32703577 RESULT

• Zysko D, Gajek J, Kozluk E, Mazurek W. Electrocardiographic characteristics of atrioventricular block induced by tilt testing. Europace. 2009 Feb;11(2):225-30. doi: 10.1093/europace/eun299. Epub 2008 Nov 5.

  PMID: 18987129 RESULT

• Klank-Szafran M, Stec S, Sledz J, Janion M. [Radiofrequency ablation and cardioneuroablation for AVNRT and atrioventricular block]. Kardiol Pol. 2010 Jun;68(6):720-4. Polish.

  PMID: 20806214 RESULT

• Pachon JC, Pachon EI, Pachon JC, Lobo TJ, Pachon MZ, Vargas RN, Jatene AD. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005 Jan;7(1):1-13. doi: 10.1016/j.eupc.2004.10.003.

  PMID: 15670960 RESULT

• 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.

  PMID: 32817835 RESULT

MeSH Terms

Interventions

Electrophysiologic Techniques, Cardiac

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Krystian Josiak, MD, PhD

  4th Military Clinical Hospital with Polyclinic, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krystian Josiak, MD, PhD

CONTACT

+48 516625985; kjosiak@4wsk.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Krystian Josiak, MD, PhD

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 25, 2021
• Study Start: January 2, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)