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Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation?
Sponsor: Institut d'Investigació Biomèdica de Bellvitge
Summary
Reflex syncope is the most common form of syncope. It can lead to injuries and affect quality of life. Nonpharmacological and medical therapies have limited effectiveness. In certain patients, cardiac pacing seem to be beneficial. More recently cardioneuroablation (CNA) has emerged as a novel therapy for reflex syncope. The investigators aim to determine whether CNA is more effective than cardiac pacing at reducing the rate of cardioinhibitory-type reflex syncope.
Official title: Recurrent Cardioinhibitory Reflex Syncope. PermANent PAcemaker Therapy or CardionEuroablation? A Multicenter RAndomized Clinical Trial
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-11-22
Completion Date
2027-02-22
Last Updated
2024-01-25
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (10)
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Alicante, Spain
Hospital Universitari General de Castellón
Castellon, Castellón, Spain
Hospital Universitario Álvaro Cunqueiro de Vigo
Vigo, Pontevedra, Spain
Hospital del Mar
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, Spain
Hospital Universitari Dr. Josep Trueta
Girona, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain