BridgeMD
New treatment option for Bradycardia
Official title Cardioneuroablation for Bradyarrhythmia
ClinicalTrials.gov ID: NCT06288633
What this study is testing
- What it's testing
- This is a multicenter prospective randomized blind controlled trial with a sham procedure group of the efficacy and safety of cardioneuroablation as a method of treating symptomatic bradycardia without a permanent pacemaker implantation
- 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 65
You may be able to join if
- Any of the following variants of bradyarrhythmia in patients aged 18-65 years: (1.1.) Symptomatic sinus bradycardia or bradycardia due to...
- Positive reaction to physical activity and/or atropine test: (2.1.) Increase in sinus rhythm frequency ≥25% or \>90 beats/min. (2.2.) The transition...
- Sinus rhythm at the time of switching on
You likely can't join if
- Anamnesis of injury during syncopation due to bradycardia, except in the case when the patient refused to implant an electrocardiostimulator for his...
- Constant intake of antiarrhythmic drugs (for PVC, AF, etc.);
- The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator;
- Drug-induced sinus bradycardia and/or atrioventricular block;
- Bradycardia due to electrolyte imbalance (e.g. hyperkalemia);
- Bradycardia due to hypothyroidism or other reversible conditions;
See the full eligibility criteria
- Any of the following variants of bradyarrhythmia in patients aged 18-65 years: (1.1.) Symptomatic sinus bradycardia or bradycardia due to atrioventricular blockade, including transient. (1.2.) Severe asymptomatic sinus...
- Positive reaction to physical activity and/or atropine test: (2.1.) Increase in sinus rhythm frequency ≥25% or \>90 beats/min. (2.2.) The transition of atrioventricular blockade of the II-III degree to the 1st degree or...
- Sinus rhythm at the time of switching on
- Anamnesis of injury during syncopation due to bradycardia, except in the case when the patient refused to implant an electrocardiostimulator for his own reasons in writing;
- Constant intake of antiarrhythmic drugs (for PVC, AF, etc.);
- The presence of an implanted pacemaker, a heart contractility modulation device, a cardioverter defibrillator;
- Drug-induced sinus bradycardia and/or atrioventricular block;
- Bradycardia due to electrolyte imbalance (e.g. hyperkalemia);
- Bradycardia due to hypothyroidism or other reversible conditions;
- No reaction to the administration of atropine (up to a maximum dose of 0.2 mg / kg);
- Proven association of bradyarrhythmia with episodes of apnea/hypopnea in obstructive sleep apnea syndrome;
- Clinically significant coronary artery disease;
- Postinfarction cardiosclerosis;
- Hemodynamically significant congenital heart defects, including operated ones;
- Stroke or transient ischemic attack \<3 months;
- Open heart surgery in the anamnesis;
- Catheter interventions on coronary arteries or for cardiac arrhythmias \<3 days;
- Conditions after percutaneous coronary angioplasty \<3 months;
- Anamnesis of stable ventricular tachycardia on the background of bradycardia;
- Pregnancy or breastfeeding period
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, 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.