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

NCT ID: NCT04816864

Last Updated: 2022-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-02

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Permanent His Bundle Pacing Permanent Left Bundle Branch Pacing

Keywords

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His bundle pacing left bundle branch pacing extracardiac vagal nerve stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ECANS started from the right vagus nerve

superior ECANS and ultrasonography guided inferior ECANS

Group Type ACTIVE_COMPARATOR

extracardiac vagal nerve stimulation (ECANS) + EPS

Intervention Type 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

superior ECANS and ultrasonography guided inferior ECANS

Group Type ACTIVE_COMPARATOR

extracardiac vagal nerve stimulation (ECANS) + EPS

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Subcarpathian Center for Cardiovascular Intervention

UNKNOWN

Sponsor Role collaborator

Mazovian Speciality Hospital

UNKNOWN

Sponsor Role collaborator

Wroclaw Medical University

OTHER

Sponsor Role collaborator

4th Military Clinical Hospital with Polyclinic, Poland

OTHER

Sponsor Role lead

Responsible Party

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Krystian Josiak

Krystian Josiak, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Krystian Josiak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

4th Military Clinical Hospital with Polyclinic, Poland

Locations

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4th Military Hospital, Cardiology Department

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status RECRUITING

Mazovian Speciality Hospital, Cardiology Department

Radom, Masovian Voivodeship, Poland

Site Status RECRUITING

Subcarpathian Center for Cardiovascular Intervention

Sanok, Podkarpackie Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Krystian Josiak, MD, PhD

Role: CONTACT

Phone: +48 516625985

Email: [email protected]

Facility Contacts

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Krystian Josiak, MD, PhD

Role: primary

Jarosław Kosior, MD, PhD

Role: primary

Sebastion Stec, prof, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 29535066 (View on PubMed)

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.

Reference Type RESULT
PMID: 24509688 (View on PubMed)

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.

Reference Type RESULT
PMID: 27016475 (View on PubMed)

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.

Reference Type RESULT
PMID: 24733700 (View on PubMed)

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.

Reference Type RESULT
PMID: 25446158 (View on PubMed)

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.

Reference Type RESULT
PMID: 32703577 (View on PubMed)

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.

Reference Type RESULT
PMID: 18987129 (View on PubMed)

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.

Reference Type RESULT
PMID: 20806214 (View on PubMed)

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.

Reference Type RESULT
PMID: 15670960 (View on PubMed)

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.

Reference Type RESULT
PMID: 32817835 (View on PubMed)

Other Identifiers

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4thMilitaryH

Identifier Type: -

Identifier Source: org_study_id