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Published online: 2024-11-25

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GENTLE-PACE — A multicenter, randomized, double-blinded research study comparinG the Efficacy and safety of cardioNeuroablaTion vs. permanent pacing in patients with an implantabLE PACEmaker for symptomatic bradycardia

Przemysław Skoczyński12, Bruno Hrymniak1, Bartosz Skonieczny1, Bartosz Biel1, Krystian Josiak1, Bartosz Krakowiak1, Kuba Ptaszkowski34, Krzysztof S. Gołba56, Jacek Bednarek56, Jarosław Kosior7, Edyta Stodółkiewicz-Nowarska8, Anna Skotny9, Patrycja Aktanorowicz110, Agnieszka Andrejków10, Anna Ratajska1112, Magdalena Zając13, Waldemar Banasiak114, Adrian Doroszko114, Dorota Zyśko114, Sebastian Stec15, José Carlos Pachón-Mateos1617, Dariusz Jagielski114

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References

  1. Kusumoto FM, Schoenfeld MH, Barrett C, et al. 2018 ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay: Executive summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Heart Rhythm. 2018: S1547. 5271; 18: 31126–3.
  2. Glikson M, Nielsen JC, Kronborg MB, et al. ESC Scientific Document Group. 2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy. Eur Heart J. 2021; 42(35): 3427–3520.
  3. Udo EO, Zuithoff NPA, van Hemel NM, et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: the FOLLOWPACE study. Heart Rhythm. 2012; 9(5): 728–735.
  4. Shirwaiker A, William J, Mariani JA, et al. Long-Term Implications of Pacemaker Insertion in Younger Adults: A Single Centre Experience. Heart Lung Circ. 2022; 31(7): 993–998.
  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. Piotrowski R, Baran J, Sikorska A, et al. Cardioneuroablation for Reflex Syncope: Efficacy and Effects on Autonomic Cardiac Regulation-A Prospective Randomized Trial. JACC Clin Electrophysiol. 2023; 9(1): 85–95.
  8. Brignole M, Aksu T, Calò L, et al. Clinical controversy: methodology and indications of cardioneuroablation for reflex syncope. Europace. 2023; 25(5).
  9. Wileczek A, Stodolkiewicz-Nowarska E, Reichert A, et al. Reevaluation of indications for permanent pacemaker implantation after cardioneuroablation. Kardiol Pol. 2023; 81(12): 1272–1275.
  10. Stec S, Wileczek A, Reichert A, et al. Shared Decision Making and Cardioneuroablation Allow Discontinuation of Permanent Pacing in Patients with Vagally Mediated Bradycardia. J Cardiovasc Dev Dis. 2023; 10(9).
  11. De Greef Y, Ströker E, Schwagten B, et al. Complications of pulmonary vein isolation in atrial fibrillation: predictors and comparison between four different ablation techniques: Results from the MIddelheim PVI-registry. Europace. 2018; 20(8): 1279–1286.
  12. Sutton R. Syncope in Patients with Pacemakers. Arrhythm Electrophysiol Rev. 2015; 4(3): 189–192.
  13. Debruyne P, Rossenbacker T, Janssens L, et al. Unifocal Right-Sided Ablation Treatment for Neurally Mediated Syncope and Functional Sinus Node Dysfunction Under Computed Tomographic Guidance. Circ Arrhythm Electrophysiol. 2018; 11(9): e006604.
  14. Blackwelder W. “Proving the Null Hypothesis” in clinical trials. Controlled Clinical Trials. 1981; 2(1): 67.
  15. Sealed Envelope Ltd. 2012. Power calculator for binary outcome non-inferiority trial. [Online] . https://www.sealedenvelope.com/power/binary-noninferior/ (Sep 19 2022).
  16. Kutarski A, Jacheć W, Kosior J, et al. Discontinuation of cardiac implantable electronic device therapy after transvenous lead extraction. Kardiol Pol. 2023; 81(11): 1113–1121.
  17. Piotrowski R, Zuk A, Baran J, et al. Cardioneuroablation for asystolic reflex syncope-left or right atrial approach? A randomized prospective Roman II study-preliminary results. Europace. 2023; 25(Supplement_1).
  18. DINERVAPACE Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction NCT05186220.
  19. GAPS Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome. NCT04149886.
  20. Stec S, Jankowska-Polańska B, Jagielski D, et al. 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. Cardiol J. 2022; 29(6): 1031–1036.
  21. TELE-SPACER Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block. NCT05774262.
  22. CARDIOSYRE Cardioneuroablation in Reflex Syncope. NCT05513755. 2019.
  23. CAMPAIGN Treatment Strategy of Vasovagal Syncope. NCT05803148.
  24. PANACEA Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation. NCT05855603.
  25. CardNMH3 Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope. NCT04755101.
  26. Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation. NCT06058468.