RecruitingNot ApplicableNCT07671898

Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias

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


Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Enrollment

60 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Focal Cryoablation and a procedure called Radiofrequency Catheter Ablation for people with atrioventricular block, bradycardia, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFocal Cryoablation

Focal cryoablation of right atrial ganglionated plexi using Freezor™ Xtra 6mm catheter (Medtronic) at -75°C for 240 seconds per application. 3-5 applications per GP zone. Positioned by fluoroscopy and impedance-based tracking in EnSite™ X system.

PROCEDURERadiofrequency Catheter Ablation

Radiofrequency ablation of right atrial ganglionated plexi using TactiFlex™ SE catheter (Abbott) with power up to 45W, temperature 50°C, target AI 45, with irrigation. 3-5 applications per GP zone. Guided by EnSite™ X mapping system and spectral analysis (OTNF).


Locations(1)

Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, Russia

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NCT07671898


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