90
Participants
Start Date
November 22, 2023
Primary Completion Date
November 22, 2026
Study Completion Date
February 22, 2027
Cardioneuroablation
"Ganglionated plexi will be localized using an empirical anatomical approach and/or a fractionated electrogram-based strategy.~Point-by-point ablation will be performed using radiofrequency energy and an irrigated tip contact force sensing ablation catheter in a power control mode (35-50 W; AI, 350-500; LSI, 4.5-5.5). The right superior GP (RSGP), left superior GP (LSGP) and posterior left GP (PMLGP) will be targeted during CNA. Radiofrequency applications in other GPs will be left at the discretion of the operator.~At the end of the procedure, another EP study and atropine test will be performed. Clinical endpoints for completion of the CNA will be: 1) a HR increase \>20% if the CNA was performed under general anesthesia/deep sedation; 2) improved electrophysiological parameters; 3) significant reduction in atropine response (HR increase \<10% after atropine); and 4) in case of using extracardiac vagal stimulation, lack of response."
Permanent pacemaker therapy
All patients in the pacemaker group will receive a dual-chamber pacemaker that has the ability to be programmed in the DDD-CLS algorithm mode (or failing this, a dual-chamber pacemaker with RDR algorithm).
NOT_YET_RECRUITING
Hospital Universitari General de Castellón, Castellon
NOT_YET_RECRUITING
Hospital Universitari Dr. Josep Trueta, Girona
NOT_YET_RECRUITING
Hospital Universitario Álvaro Cunqueiro de Vigo, Vigo
NOT_YET_RECRUITING
Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife
NOT_YET_RECRUITING
Hospital Universitari i Politècnic La Fe, Valencia
NOT_YET_RECRUITING
Hospital Clínico Universitario Lozano Blesa, Zaragoza
NOT_YET_RECRUITING
Hospital Universitario San Juan de Alicante, Sant Joan d'Alacant
NOT_YET_RECRUITING
Hospital del Mar, Barcelona
NOT_YET_RECRUITING
Hospital de la Santa Creu i Sant Pau, Barcelona
RECRUITING
Hospital Universitario de Bellvitge, Barcelona
Institut d'Investigació Biomèdica de Bellvitge
OTHER