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Freezing or burning heart nerves: which works best for slow heartbeat?

NCT ID NCT07671898

Disease control Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests two ways to treat a slow heart rate caused by overactive nerves, without using a permanent pacemaker. One method uses freezing (cryoablation) and the other uses burning (radiofrequency) to calm the nerves. Sixty adults aged 18 to 60 with symptoms like fainting or dizziness will be followed for 12 months to see which approach works better and is safer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Freezor Xtra cryoablation catheter and TactiFlex SE radiofrequency ablation catheter
What this could lead to
If freezing works as well as burning, it may offer a safer, less painful option for treating slow heart rates without a permanent pacemaker.
What could go wrong
This is a small, non-randomized study with only 60 people. Results may not apply to everyone, and both procedures carry risks like bleeding, heart rhythm problems, or the need for a pacemaker later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrioventricular block Bradycardia sick sinus syndrome syncope, familial vasovagal Syncope, Vasovagal

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrioventricular block Bradycardia Sick sinus syndrome Syncope, vasovagal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Tomsk, Tomsk Oblast, 634012, Russia

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