Prospective Non-Randomized Comparison of Point-by-Point Cryoablation Using Freezor™ Xtra Versus Radiofrequency Ablation Using TactiFlex™ SE of Parasympathetic Ganglia (Cardioneuroablation) in Patients With Vagally-Mediated Bradyarrhythmias
Bradyarrhythmias are conditions where the heart beats too slowly, causing symptoms like dizziness, fainting, and fatigue. In some patients, these slow heart rhythms are caused by overactivity of the vagus nerve (the part of the nervous system that slows the heart down). Cardioneuroablation (CNA) is a catheter-based procedure that targets and reduces the effect of these overactive nerves on the heart. It is an alternative to permanent pacemaker implantation, especially for younger patients. Traditionally, CNA is performed using radiofrequency (RF) energy to create small burns in specific areas of the heart. This study investigates whether focal cryoablation (freezing technology using the Freezor™ Xtra catheter) is as safe and effective as standard RF ablation for CNA. This is a prospective, non-randomized study. Participants will receive either RF ablation (N=30) or cryoablation (N=30). The study will evaluate the recurrence of slow heart rhythms and fainting episodes, as well as any complications, over 12 months of follow-up.
• Age 18 to 60 years;
• Symptomatic bradycardia (sinus bradycardia or bradycardia due to atrioventricular block, including transient);
• Severe asymptomatic sinus bradycardia (heart rate less than 30 beats per minute);
• Transient second- or third-degree atrioventricular block;
• Persistent second-degree atrioventricular block;
• Rhythm pauses greater than 6 seconds;
• Recurrent syncope or presyncope with documented association with bradycardia (without trauma);
• Positive response to atropine (heart rate increase ≥25% from baseline or \>90 beats per minute) OR positive response to exercise (heart rate increase ≥25% from baseline or \>90 beats per minute, OR conversion of second- or third-degree atrioventricular block to first-degree block or complete normalization of atrioventricular conduction during sinus rhythm);