open access

Vol 29, No 6 (2022)
Study Protocol
Submitted: 2022-07-02
Accepted: 2022-10-31
Published online: 2022-11-07
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Rationale and design of SAN.OK randomized clinical trial and registry: Comparison of the effects of evidence-based pacemaker therapy and cardioneuroablation in sinus node dysfunction

Sebastian Stec12, Beata Jankowska-Polańska3, Dariusz Jagielski4, Antoni Wileczek12, Krystian Josiak45, Janusz Śledź2, Agnieszka Reichert6, Anna Kustroń2, Dorota Zyśko47, Bartosz Skonieczny4, Artur Fedorowski8, Anna Ratajska910, Magdalena Zając11, Dagmara Hering12, Wojciech Wąsek13, Edyta Stodółkiewicz-Nowarska14
DOI: 10.5603/CJ.a2022.0103
Pubmed: 36385604
Cardiol J 2022;29(6):1031-1036.
  1. Division of Electrophysiology, Cardioneuroablation, Catheter Ablation and Cardiac Stimulation, Subcarpathian Center for Cardiovascular Intervention, Sanok, Poland
  2. Elmedica, EP-Network, SKA, Poland
  3. Center for Research and Innovation, 4th Military Hospital, Wroclaw, Poland
  4. Department of Cardiology, Center for Heart Diseases, 4th Military Hospital, Wroclaw, Poland
  5. Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland
  6. Medical Center, Sabamed, Rzeszow, Poland
  7. Department of Emergency Medicine, Wroclaw Medical University, Wroclaw, Poland
  8. Department of Cardiology, Karolinska University Hospital, Department of Medicine, Karolinska Institute, Stockholm, Sweden
  9. Psychological Therapeutic and Research Center, University Hospital No. 2, Bydgoszcz, Poland
  10. Department of Humanization, Medicine and Sexology, Institute of Health Sciences, University of Zielona Gora, Poland
  11. Department of Pedagogy, University of Kazimierz Wielki, Bydgoszcz, Poland
  12. Department of Hypertension and Diabetology, Medical University of Gdansk, Poland
  13. Department of Internal Medicine, Institute of Health Sciences, College of Medical Sciences, Rzeszow University, Poland
  14. Department of Interventional Cardiology, Cardiovascular Center, American Heart of Poland, Chrzanow, Poland

open access

Vol 29, No 6 (2022)
Study protocol — Clinical cardiology
Submitted: 2022-07-02
Accepted: 2022-10-31
Published online: 2022-11-07


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Rationale and design of SAN.OK randomized clinical trial and registry: Comparison of the effects of evidence-based pacemaker therapy and cardioneuroablation in sinus node dysfunction


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Vol 29, No 6 (2022)

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Study Protocol



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Cardiol J 2022;29(6):1031-1036.


Sebastian Stec
Beata Jankowska-Polańska
Dariusz Jagielski
Antoni Wileczek
Krystian Josiak
Janusz Śledź
Agnieszka Reichert
Anna Kustroń
Dorota Zyśko
Bartosz Skonieczny
Artur Fedorowski
Anna Ratajska
Magdalena Zając
Dagmara Hering
Wojciech Wąsek
Edyta Stodółkiewicz-Nowarska

References (20)
  1. Glikson M, Nielsen JC, Kronborg MB, et al. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021; 42(35): 3427–3520.
  2. Brignole M, Moya A, de La, et al. 2018 ESC Guidelines for the diagnosis and management of syncope. ESC Scientific Document Group. Eur Heart J. 2018; 39: 1883–1948.
  3. Brignole M, Moya A, de Lange FJ, et al. ESC Scientific Document Group. Practical Instructions for the 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018; 39(21): e43–e80.
  4. Tułecki Ł, Polewczyk A, Jacheć W, et al. A study of major and minor complications of 1500 transvenous lead extraction procedures performed with optimal safety at two high-volume referral centers. Int J Environ Res Public Health. 2021; 18(19).
  5. Pachon JC, Pachon EI, Pachon JC, et al. "Cardioneuroablation"--new treatment for neurocardiogenic syncope, functional AV block and sinus dysfunction using catheter RF-ablation. Europace. 2005; 7(1): 1–13.
  6. Pachon JC, Pachon EI, Cunha Pachon MZ, et al. Catheter ablation of severe neurally meditated reflex (neurocardiogenic or vasovagal) syncope: cardioneuroablation long-term results. Europace. 2011; 13(9): 1231–1242.
  7. Pachon M JC, Pachon M EI, Santillana P TG, et al. Simplified method for vagal effect evaluation in cardiac ablation and electrophysiological procedures. JACC Clin Electrophysiol. 2015; 1(5): 451–460.
  8. Shivkumar K, Ajijola OA, Anand I, et al. Clinical neurocardiology defining the value of neuroscience-based cardiovascular therapeutics. J Physiol. 2016; 594(14): 3911–3954.
  9. Yao Y, Shi R, Wong T, et al. Endocardial autonomic denervation of the left atrium to treat vasovagal syncope. Circ Arrhythm Electrophysiol. 2012; 5(2): 279–286.
  10. Aksu T, Golcuk E, Yalin K, et al. Simplified cardioneuroablation in the treatment of reflex syncope, functional AV block, and sinus node dysfunction. Pacing Clin Electrophysiol. 2016; 39(1): 42–53.
  11. Qin Mu, Zhang Yu, Liu Xu, et al. Atrial ganglionated plexus modification: a novel approach to treat symptomatic sinus bradycardia. JACC Clin Electrophysiol. 2017; 3(9): 950–959.
  12. Piotrowski R, Baran J, Kułakowski P, et al. Cardioneuroablation using an anatomical approach: a new and promising method for the treatment of cardioinhibitory neurocardiogenic syncope. Kardiol Pol. 2018; 76(12): 1736–1738.
  13. Aksu T, Erdem Guler T. Cardioneuroablation in the management of vasovagal syncope, sinus node dysfunction and functional atrioventricular block: patient selection based on supporting evidence. J Atr Fibrillation. 2020; 13(1): 2396.
  14. Stec S, Dobaj Ł, Śledź A, et al. Cardioneuroablation for management of cardioinhibitory vasovagal syncope and pacemaker complications. HeartRhythm Case Rep. 2020; 6(8): 531–534.
  15. Wileczek A, Polewczyk A, Kluk M, et al. Ultrasound-guided imaging for vagus nerve stimulation to facilitate cardioneuroablation for the treatment of functional advanced atrioventricular block. Indian Pacing Electrophysiol J. 2021; 21(6): 403–406.
  16. Aksu T, De Potter T, John L, et al. Procedural and short-term results of electroanatomic-mapping-guided ganglionated plexus ablation by first-time operators: A multicenter study. J Cardiovasc Electrophysiol. 2022; 33(1): 117–122.
  17. Rivasi G, Ungar A, Moya A, et al. Syncope: new solutions for an old problem. Kardiol Pol. 2021; 79(10): 1068–1078.
  18. ROMAN registry (Cardioneuroablation for Reflex Syncope (ROMAN): NCT 03903744.
  19. Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome (GAPS): NCT 04149886.
  20. Cardioneuroablation versus pacemaker implantation for the treatment of symptomatic sinus node dysfunction (DINERVAPACE): NCT 051862.


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