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New treatment option for Bradycardia
Official title Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias
ClinicalTrials.gov ID: NCT07671898
What this study is testing
- What it's testing
- 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).
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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-...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tomsk, Tomsk Oblast, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tomsk, Tomsk Oblast, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.