Cardioinhibitory Reflex Syncope. Permanent Pacemaker Therapy or Cardioneuroablation? (PANACEA)
Reflex Syncope
About this trial
This is an interventional treatment trial for Reflex Syncope focused on measuring Cardioneuroablation, Permanent cardiac pacing, Vasovagal syncope
Eligibility Criteria
Inclusion Criteria: Aged more than 40 years. Having a 12-month history that includes at least two documented episodes of spontaneous reflex syncope or one episode that led to injury in addition to at least two presyncopal events, refractory to all recommended types of standard treatment. Bradycardia-syncope correlation (at least 3 seconds of asystole due to sinus arrest or atrio-ventricular block) confirmed by ECG during spontaneous syncope. If lacking ECG evidence during spontaneous syncope, a cardioinhibitory response (VASIS type 2A or 2B) on tilt test. Displaying indicators for pacing such as those suggested in the ESC guidelines for a class I recommendation for patients with reflex syncope. Significantly decreased quality of life due to syncope. Sinus rhythm on ECGs. Obtained written informed consent. Exclusion Criteria: Intrinsic sinus or atrioventricular nodal disease with a proven indication for permanent pacemaker implantation. Evidence of structural heart disease. Contraindications to ablation in the right or left atrium. Life expectancy <12 months. Lacking willingness to comply with the randomization procedure.
Sites / Locations
- Hospital Universitario San Juan de Alicante
- Hospital Universitari General de Castellón
- Hospital Universitario Álvaro Cunqueiro de Vigo
- Hospital del Mar
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitario de Bellvitge
- Hospital Universitari Dr. Josep Trueta
- Hospital Universitario Nuestra Señora de Candelaria
- Hospital Universitari i Politècnic La Fe
- Hospital Clínico Universitario Lozano Blesa
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cardioneuroablation
Dual-chamber pacemaker
Bi-atrial ablation of GPs: CARDIONEUROABLATION (Group A, n = 45)
Implant of a dual-chamber CLS PACEMAKER* (Group B, n = 45). *or failing this, a dual-chamber pacemaker with RDR algorithm