Actively Recruiting
Cardioneuroablation for Bradyarrhythmia
Led by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · Updated on 2024-03-05
106
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
F
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Lead Sponsor
M
Meshalkin National Medical Research Center, Ministry of Health of Russian Federation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Cardioneuroablation for Bradyarrhythmia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Symptomatic sinus bradycardia or bradycardia due to atrioventricular block, including transient
- Severe asymptomatic sinus bradycardia with rhythm frequency below 30 beats per minute
- Transient second to third degree atrioventricular block or permanent second degree block
- Repeated fainting or pre-fainting states linked to bradycardia without injury
- Rhythm pauses longer than 6 seconds
- Positive reaction to physical activity and/or atropine test showing increase in sinus rhythm by 25% or more or above 90 beats per minute
- Sinus rhythm present at the time of enrollment
You will not qualify if you...
- History of injury during syncope caused by bradycardia unless patient refused pacemaker implantation in writing
- Regular use of antiarrhythmic drugs
- Presence of implanted pacemaker, heart contractility modulation device, or cardioverter defibrillator
- Drug-induced sinus bradycardia or atrioventricular block
- Bradycardia caused by electrolyte imbalance such as hyperkalemia
- Bradycardia due to hypothyroidism or other reversible conditions
- No response to atropine administration up to 0.2 mg/kg
- Bradyarrhythmia linked to obstructive sleep apnea episodes
- Clinically significant coronary artery disease
- Post-infarction cardiosclerosis
- Hemodynamically significant congenital heart defects, including operated ones
- Stroke or transient ischemic attack within 3 months
- History of open heart surgery
- Catheter interventions for coronary arteries or arrhythmias within 3 days
- Percutaneous coronary angioplasty within 3 months
- History of stable ventricular tachycardia with bradycardia
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Almazov National Medical Research Centre
Saint Petersburg, Russia
Actively Recruiting
Research Team
A
Aleksandr Vakhrushev, PhD
CONTACT
E
Evgeny Mikhaylov, PhD, Prof.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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