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Study Protocol
Published online: 2024-11-25
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
DOI: 10.5603/cj.100718
Pubmed: 39584414
Abstract
Not available
Keywords: pacemakercardioneuroablationCNAcardioneuromodulationsinus node dysfunctionSNDatrioventricular blockAVBrandomized clinical trialRCT
References
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Brignole M, Aksu T, Calò L, et al. Clinical controversy: methodology and indications of cardioneuroablation for reflex syncope. Europace. 2023; 25(5).
- 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.
- 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).
- 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.
- Sutton R. Syncope in Patients with Pacemakers. Arrhythm Electrophysiol Rev. 2015; 4(3): 189–192.
- 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.
- Blackwelder W. “Proving the Null Hypothesis” in clinical trials. Controlled Clinical Trials. 1981; 2(1): 67.
- Sealed Envelope Ltd. 2012. Power calculator for binary outcome non-inferiority trial. [Online] . https://www.sealedenvelope.com/power/binary-noninferior/ (Sep 19 2022).
- 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.
- 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).
- DINERVAPACE Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction NCT05186220.
- GAPS Cardiac Ganglionated Plexus Ablation Before Permanent Pacemaker Implantation in Patients With Sick Sinus Syndrome. NCT04149886.
- 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.
- TELE-SPACER Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block. NCT05774262.
- CARDIOSYRE Cardioneuroablation in Reflex Syncope. NCT05513755. 2019.
- CAMPAIGN Treatment Strategy of Vasovagal Syncope. NCT05803148.
- PANACEA Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation. NCT05855603.
- CardNMH3 Efficacy of a Right-sided Ablation of the Anterior Ganglionated Plexus for Neurally Mediated Syncope. NCT04755101.
- Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation. NCT06058468.