Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias (NCT07671898) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias
Russia60 participantsStarted 2024-09-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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);
Exclusion Criteria:
* 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);
* Bradyarrhythmia secondary to hypothyroidism;
* Bradyarrhythmia secondary to obstructive sleep apnea syndrome;
* Absence of response to pharmacological denervation (no heart rate increase after atropine administration up to maximum dose of 0.2 mg/kg);
* Clinically significant coronary artery disease;
* Post-myocardial infarction cardiosclerosi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recurrence of Bradyarrhythmia or Syncope
Timeframe: 12 months
Trial details
NCT IDNCT07671898
SponsorTomsk National Research Medical Center of the Russian Academy of Sciences