About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Chronic antiarrhythmic drug therapy (ongoing);
Presence of implanted pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator;
Bradyarrhythmia secondary to medications;
Bradyarrhythmia secondary to electrolyte imbalance (hyperkalemia);
Trial design
Treatments tested in this trial
- Focal Cryoablation
- Radiofrequency Catheter Ablation