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| Name | Class |
|---|---|
| Subcarpathian Center for Cardiovascular Intervention | UNKNOWN |
| Mazovian Speciality Hospital | UNKNOWN |
| Wroclaw Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECANS started from the right vagus nerve | Active Comparator | superior ECANS and ultrasonography guided inferior ECANS |
|
| ECANS started from the left vagus nerve | Active Comparator | superior ECANS and ultrasonography guided inferior ECANS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| A nonsignificant increase in pacing threshold | below the permanently programmed impulse amplitude of HB/LBB electrode induced by ECANS | 0-12 months after HB/LBB pacemaker implantation |
| Prolongation of the stimulus-QRS interval during HB/LBB pacing induced by ECANS |
| Measure | Description | Time Frame |
|---|---|---|
| Any arrhythmia induced by ECANS | 0-12 months after HB/LBB pacemaker implantation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krystian Josiak, MD, PhD | Contact | +48 516625985 | kjosiak@4wsk.pl |
| Name | Affiliation | Role |
|---|---|---|
| Krystian Josiak, MD, PhD | 4th Military Clinical Hospital with Polyclinic, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4th Military Hospital, Cardiology Department | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-981 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29535066 | Result | 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. | |
| 24509688 | 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. |
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|
| 0-12 months after HB/LBB pacemaker implantation |
| Mazovian Speciality Hospital, Cardiology Department | Recruiting | Radom | Masovian Voivodeship | 26-617 | Poland |
|
| Subcarpathian Center for Cardiovascular Intervention | Recruiting | Sanok | Podkarpackie Voivodeship | 38-500 | Poland |
|
| 27016475 | 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. |
| 24733700 | 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. |
| 25446158 | 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. |
| 32703577 | 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. |
| 18987129 | 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. |
| 20806214 | 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. |
| 15670960 | 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. |
| 32817835 | 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. |
| ID | Term |
|---|---|
| D022062 | Electrophysiologic Techniques, Cardiac |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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