Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?

NARecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

November 22, 2023

Primary Completion Date

November 22, 2026

Study Completion Date

February 22, 2027

Conditions
Reflex Syncope
Interventions
PROCEDURE

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."

DEVICE

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).

Trial Locations (10)

12004

NOT_YET_RECRUITING

Hospital Universitari General de Castellón, Castellon

17007

NOT_YET_RECRUITING

Hospital Universitari Dr. Josep Trueta, Girona

36312

NOT_YET_RECRUITING

Hospital Universitario Álvaro Cunqueiro de Vigo, Vigo

38010

NOT_YET_RECRUITING

Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife

46026

NOT_YET_RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

50009

NOT_YET_RECRUITING

Hospital Clínico Universitario Lozano Blesa, Zaragoza

03550

NOT_YET_RECRUITING

Hospital Universitario San Juan de Alicante, Sant Joan d'Alacant

08003

NOT_YET_RECRUITING

Hospital del Mar, Barcelona

08025

NOT_YET_RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

08907

RECRUITING

Hospital Universitario de Bellvitge, Barcelona

All Listed Sponsors
lead

Institut d'Investigació Biomèdica de Bellvitge

OTHER