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Permanent His Bundle PacingHIS-STORYNCT04816864

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

A study testing extracardiac vagal nerve stimulation (ECANS) + EPS in people with Permanent His Bundle Pacing and Permanent Left Bundle Branch Pacing, run by 4th Military Clinical Hospital with Polyclinic, Poland at 3 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
extracardiac vagal nerve stimulation (ECANS) + EPS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesPoland
Study dates
2 Jan 2021to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • use of medications that may affect the parasympathetic system
  • a history of cardiac surgery
  • a history of ablation due to arrhythmia

Trial locations and contacts

3 sites in 1 country.

Krystian Josiak, MD, PhD contact

+48 516625985

kjosiak@4wsk.pl

Poland3 sites, 3 recruiting

  • Mazovian Speciality Hospital, Cardiology Department

    Radom, Masovian Voivodeship, 26-617

    Jarosław Kosior, MD, PhD, +48 3613676, jaroslaw.kosior@icloud.com

    Jarosław Kosior, MD, PhD

    Recruiting

  • Subcarpathian Center for Cardiovascular Intervention

    Sanok, Podkarpackie Voivodeship, 38-500

    Sebastion Stec, prof, MD, +48 600298022, smstec@wp.pl

    Sebastian Stec, prof, MD

    Recruiting

  • 4th Military Hospital, Cardiology Department

    Wroclaw, Lower Silesian Voivodeship, 50-981

    Krystian Josiak, MD, PhD, +48 261660223, kjosiak@4wsk.pl

    Dorota Zyśko, prof, MD

    Recruiting

Other trials in Poland

About this study

Official title: Safety and Efficacy of HIs Bundle Pacing Validated by electrophySiological STudy, autonOmic Tests and extRacardiac Vagal Nerve Stimulation (HIS-STORY)

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.

Read the 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.

Being tested
extracardiac vagal nerve stimulation (ECANS) + EPS
Keywords
His bundle pacing, left bundle branch pacing, extracardiac vagal nerve stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • extracardiac vagal nerve stimulation (ECANS) + EPSDiagnostic 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.
Study groups in NCT04816864
Study groupRoleWhat they receive
ECANS started from the right vagus nerveActive comparatorsuperior ECANS and ultrasonography guided inferior ECANS
Receives: Diagnostic Test: extracardiac vagal nerve stimulation (ECANS) + EPS
ECANS started from the left vagus nerveActive comparatorsuperior ECANS and ultrasonography guided inferior ECANS
Receives: Diagnostic Test: extracardiac vagal nerve stimulation (ECANS) + EPS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 0-12 months after HB/LBB pacemaker implantation

Secondary outcomes (2)

  1. A nonsignificant increase in pacing threshold

    below the permanently programmed impulse amplitude of HB/LBB electrode induced by ECANS

    Measured: 0-12 months after HB/LBB pacemaker implantation

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

    Measured: 0-12 months after HB/LBB pacemaker implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2021
  2. Study start2 Jan 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04816864
Sponsor's protocol ID
4thMilitaryH
Acronym
HIS-STORY
Status last verified
Dec 2022
First submitted
21 Mar 2021
Last updated
20 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29535066

  • 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.

    PubMed 24509688

  • 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.

    PubMed 27016475

  • 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.

    PubMed 24733700

  • 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.

    PubMed 25446158

  • 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.

    PubMed 32703577

  • 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.

    PubMed 18987129

  • 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.

    PubMed 20806214

  • 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.

    PubMed 15670960

  • 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.

    PubMed 32817835

Questions about this trial

What is this clinical trial studying?

A study testing extracardiac vagal nerve stimulation (ECANS) + EPS in people with Permanent His Bundle Pacing and Permanent Left Bundle Branch Pacing, run by 4th Military Clinical Hospital with Polyclinic, Poland at 3 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Krystian Josiak, MD, PhD (+48 516625985, kjosiak@4wsk.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loss of HB/LBB capture or significant increase in pacing threshold (time frame: 0-12 months after HB/LBB pacemaker implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04816864, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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