Clinical Trial

Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias

Study acronym: CRYO-CNA vs RF
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07671898
Lead Sponsor Tomsk National Research Medical Center of the Russian Academy of Sciences
Conditions Bradycardia, Syncope, Vasovagal, Sick Sinus Syndrome, Atrioventricular Block
Enrollment 60 participants
Start Date 2024-09-01
Primary Completion 2027-12-25 (estimated)
Study Completion 2028-12-25 (estimated)
Updated on ClinicalTrials.gov 2026-06-26