Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized, single-center comparison of two CNA techniques in adults with symptomatic vagally mediated bradyarrhythmias. Participants are assigned to either focal cryoablation or RF ablation and followed for recurrence of bradyarrhythmia and syncope, as well as safety outcomes. The procedure targets parasympathetic ganglionated plexi to reduce vagal influence on the heart. Cryoablation may offer more consistent lesion formation in fatty epicardial tissue compared with RF energy. The study aims to determine if cryoablation is as effective and safe as RF ablation for cardioneuroablation.

Why it matters

Who can join: the full rules

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 cardiosclerosis;
* Hemodynamically significant congenital heart disease (including surgically corrected);
* Stable ventricular tachycardia in the setting of bradycardia;
* History of stroke or transient ischemic attack;
* Prior open-heart surgery;
* Prior catheter-based coronary artery intervention or percutaneous coronary intervention;
* Pregnancy or breastfeeding; Age less than 18 years Age greater than 60 years

Where it's running

• Cardiology Research Institute, Tomsk National Research Medical Center of the Russian Academy of Sciences
  Tomsk, Tomsk Oblast, Russia Recruiting

Study contacts

• Study coordinator: Roman E Batalov, MD, PhD
• Email: romancer@rambler.ru
• Phone: +73822558401

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Transjugular implantation of a leadless pacemaker (Aveir VR) for ventricular pacing

  This study tests whether placing an Aveir VR leadless pacemaker through the neck vein can safely provide ventricular pacing in adults with bradycardia.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07802119

• Cardioneuroablation for treating bradycardia

  This study is testing a new procedure called cardioneuroablation to see if it can help people with slow heart rates feel better without needing a permanent pacemaker.

  Recruiting Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Saint Petersburg · NCT06288633

• Registry for cardioneuroablation in patients with recurrent vasovagal syncope

  This study is collecting information to see how well a new treatment called cardioneuroablation works for people with frequent fainting spells caused by vasovagal syncope.

  Recruiting at 11 sites University Hospital, Bordeaux · Bron and 13 other locations · NCT06159764

• SPIKE FLOW endocardial pacing lead safety and performance study

  This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.

  Recruiting at 2 sites FIAB SpA · Acquaviva delle Fonti, Bari and 2 other locations · NCT07820072

• Factors Linked to Slow Heart Rate After Pulsed Field Ablation for Atrial Fibrillation

  This study looks for factors that might cause bradycardia during the hospital stay after AF ablation using pulsed field technology.

  Recruiting Wroclaw Medical University · Wroclaw, Lower Silesian Voivodeship · NCT07809347

• Conduction System Pacing Display Research During LBBAP Implant

  Researchers are testing a CSP Display System during left bundle branch area pacing pacemaker implant to see if it accurately shows heart signals compared with a standard ECG.

  Recruiting at 2 sites Medtronic Cardiac Rhythm and Heart Failure · Madurai, Tamil Nadu and 1 other locations · NCT07733960

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.