Actively Recruiting
Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial
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
52 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
Researchers are evaluating the safety and effectiveness of cardioneuroablation as a treatment for symptomatic bradycardia without the need for permanent pacemaker implantation. This multicenter, prospective, randomized, and blinded controlled trial compares cardioneuroablation with a sham procedure in patients suffering from severe bradycardia due to sinus node dysfunction and/or atrioventricular node dysfunction. The study aims to assess whether cardioneuroablation can serve as an alternative to pacemaker implantation for patients with certain heart rhythm disorders and related conditions such as vasovagal syncope.
CONDITIONS
Brief 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 heart rate below 30 beats per minute
- Transient second or third degree atrioventricular block or permanent second degree block
- Repeated fainting or near-fainting linked to bradycardia without injury
- Rhythm pauses longer than 6 seconds
- Positive response to physical activity and/or atropine test showing increased heart rate or improved atrioventricular conduction
- Sinus rhythm present at time of study enrollment
You will not qualify if you...
- History of injury from fainting due to bradycardia unless patient refused pacemaker implantation in writing
- Regular use of antiarrhythmic drugs
- Presence of an implanted pacemaker, heart contractility device, or cardioverter defibrillator
- Bradycardia caused by drug effects
- Bradycardia due to electrolyte imbalance such as high potassium levels
- Bradycardia due to hypothyroidism or other reversible causes
- No response to atropine administration at specified dose
- Bradyarrhythmia linked to sleep apnea episodes
- Significant coronary artery disease
- Post-heart attack scarring
- Significant congenital heart defects, operated or not
- Stroke or transient ischemic attack within last 3 months
- Previous open heart surgery
- Recent catheter interventions on heart or coronary arteries within 3 days
- Percutaneous coronary angioplasty within last 3 months
- History of stable ventricular tachycardia with bradycardia
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate post-procedure recovery
Participants receive either cardioneuroablation involving radiofrequency catheter ablation of ganglion plexuses in the atria or a sham electrophysiological study procedure. Both procedures are performed under local anesthesia with catheters inserted via the femoral vein.
1 procedure visit (in-person)
Duration - Up to 24 months post-procedure
Participants are monitored for safety and treatment outcomes including heart rhythm, bradycardia symptoms, and any complications after the procedure.
Multiple follow-up visits up to 24 months
Trial Site Locations
Total: 1 location
1
Almazov National Medical Research Centre
Saint Petersburg, Russia
Actively Recruiting
Research Team
A
Aleksandr Vakhrushev, PhD
E
Evgeny Mikhaylov, PhD, Prof.
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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