Cardioneuroablation Versus Pacemaker Implantation for the Treatment of Symptomatic Sinus Node Dysfunction (DINERVAPACE)
Sinus Node Dysfunction, Sick Sinus Syndrome
About this trial
This is an interventional treatment trial for Sinus Node Dysfunction focused on measuring cardioneuroablation
Eligibility Criteria
Inclusion Criteria:
- Symptomatic sinus node dysfunction (dizziness, asthenia or syncope) clearly related to an abnormal electrocardiogram finding (sinus arrest, sinoatrial block, extreme bradycardia (<40 bpm) or chronotropic incompetence in the exercise test).
- Absence of structural cardiopathy
Exclusion Criteria:
- Left ventricular ejection fraction <50%
- Severe valvular disease
- Any type of cardiomyopathy such as hypertrophic cardiomyopathy
- Previous ischemic heart disease
- QRS interval >130 ms
- Atrioventricular conduction disorder with a former indication of pacemaker implantation (atrioventricular block Mobitz II, advanced atrioventricular block, complete atrioventricular block)
- Lifetime expectance <12 months
Sites / Locations
- Hospital Clinico Universitario de SantiagoRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cardioneuroablation
Permanent pacemaker implantation
After 3D mapping of the surface of the left and right atrium and the superior vena cava (Ensite Navx or Carto system), localization of ganglion plexus (GP) will be performed either anatomically and/or by means of high frequency stimulation (HFS). The anterior and superior right sided GP will always be ablated per protocol. Other GP will be ablated according to interventional electrophysiologist judgement. The endpoint of the ablation procedure will be 1) absence of a vagal response after HFS from the right jugular vein and 2) an increase in at least 10 bpm as compared to baseline.
A dual chamber pacemaker implantation will be performed. The device will be programmed in a AAI-DDDR mode to avoid unnecessary ventricular pacing.