Permanent Pacemaker Implantation or Cardioneuroablation in Sinus Node Dysfunction (SANOK)
Sinus Node Dysfunction
About this trial
This is an interventional treatment trial for Sinus Node Dysfunction focused on measuring cardioneuroablation, pacemaker, sinus node dysfunction, bradycardia, extracardiac vagal nerve stimulation, ECG monitoring, quality of life
Eligibility Criteria
Inclusion Criteria:
- Age, 18-75 years
- Sinus node dysfunction/disease fulfilling criteria for elective pacemaker implantation according to current ESC guidelines (I, IIa, and IIb )
- Optimization of chronic disease treatment
- Ability to provide informed consent to participate in the study
- Ability to understand patient information.
Exclusion Criteria:
- Contraindications to invasive and noninvasive procedures used in the study
- Uncontrolled endocrine and systemic disorders
- Persistent atrial fibrillation
- Dilated cardiomyopathy
- Severe congenital heart valve disease or cardiomyopathy
- Functional NYHA class III/IV
- Left ventricular ejection fraction <35%
- Left atrial diameter >50 mm
- Previous catheter ablation
- Contraindications to anticoagulant treatment
- Contraindications to catheter ablation
- Chronic, advanced two- or third-degree atrioventricular block associated with structural heart disease
- Contraindications to noninvasive tests
- Pregnancy and lactation
- Previous cardiac surgery
- Implanted pacemaker device
- Neck and chest abnormalities
- Myocardial infarction in the previous 6 months
- Percutaneous coronary intervention in the previous 3 months
- Estimated survival <24 months
- Participation in another drug or medical device program
- Limited capacity to understand the study protocol or psychological disorders precluding informed consent to participate in the study.
- Any other uncontrolled chronic diseases, neck and chest abnormalities, or disorders that constitute a contraindication to catheter ablation, antiarrhytmic treatment, general anesthesia, or extracardiac vagal nerve stimulation (ECANS)
- Severe obesity (body mass index ≥40 kg/m2 )
Sites / Locations
- Center of Interventional Cardiology, Electrotherapy and Angiology G.V.M. Carint
- Medical Center SABAMEDRecruiting
- Subcarpatian Center for Cardiovascular Interventions, Laboratory of Electrophysiology, Cardioneuroablation, Ablation, Arrhythmia and Heart Electrostimulation, G.V.M. CarintRecruiting
- Department of Cardiology, Laboratory of Invasive Electrophysiology, 4th Military Teaching Hospital in Wroclaw
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Group A - PACEMAKER
Group B - CARDIONEUROABLATION
According with ESC indications for elective pacemaker implantation due to SND will referred for PM implantation.
According with ESC indications for elective PM implantation due to SND will referred for ICM/ILR implantation or prolonged ECG monitoring. Within 4 weeks patient will be screened by interdisciplinary team and autonomic tests (including atropine tests) will be performed. Than, based on atropine tests, electrophysiologic study and extracardiac vagal nerve stimulation, final indication for cardioneuroablation will be established. Biatrial, binodal cardioneuroablation will be performed with anatomical approach with bilateral extra cardiac vagal nerve stimulation during general anesthesia. Than, patient will be closely monitored and indication for PM implantation will be verified.