Comparing Two Catheter Ablation Techniques for Treating Slow Heart Rhythms Caused by Nerve Activity Using Freezor Xtra and TactiFlex SE Catheters

What this Trial Is About

Bradyarrhythmias are conditions where the heart beats too slowly, leading to symptoms like dizziness, fainting, and fatigue. These slow heart rhythms can be caused by overactivity of the vagus nerve. This research evaluates two methods of cardioneuroablation CNA, a catheter-based procedure aiming to reduce the effect of this nerve activity as an alternative to permanent pacemakers, especially in younger patients. The study compares focal cryoablation using the Freezor12 Xtra catheter and the standard radiofrequency RF ablation to assess their safety and effectiveness for treating vagally mediated bradyarrhythmias. Participants aged 18 to 60 years with symptomatic bradycardia or vasovagal syncope are assigned to either the RF ablation group or the focal cryoablation group, with 30 patients in each. RF ablation uses a TactiFlex12 SE catheter delivering up to 45W power, while cryoablation uses the Freezor12 Xtra catheter cooled to -750C for 240 seconds per application. Both procedures target ganglionated plexi in the right atrium identified by 3D mapping and spectral analysis. Procedures are performed under intravenous sedation. Participants are monitored at 6 and 12 months after the procedure, including clinical assessments, 12-lead ECG, and 24-hour Holter monitoring. Researchers measure the recurrence of bradyarrhythmias and syncope, changes in heart rate, electrophysiological parameters during the procedure, and any complications such as pericardial effusion or vascular issues. The study lasts up to 12 months of follow-up to evaluate the comparative safety and efficacy of these two CNA techniques.

Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias