Clinical Trials Logo
  1. Home
  2. Bradycardia
  3. NCT06288633

Cardioneuroablation for Bradyarrhythmia — CARDIOBOOST  

Bradycardia Clinical Trial

Official title:
Cardioneuroablation for Bradyarrhythmia (Sinus Node and Atrioventricular Node Dysfunction): a Sham-controlled Randomised Multicentre Trial

Clinical Trial Summary

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

Clinical Trial Description

Catheter ablation is a common treatment for cardiac arrhythmias. Some patients with AF ablation or AVNRT experience acceleration of sinus rhythm, the most likely cause of which is modification of autonomic tone caused by inadvertent damage to intramural autonomic ganglia and fibers. Intentional damage to these plexuses has become known as cardioneuroablation (CNA) and is currently used in patients with tachycardia-bradycardia syndrome, vegetatively caused sinus node dysfunction and atrioventricular conduction disorders, vasovagal syncopal conditions developing in a cardioinhibitory type. It is suggested that in some patients CNA may become an alternative to permanent pacemaker for the treatment of symptomatic bradyarrhythmias. This is a multicentre randomised clinical study evaluating the efficacy of cardioneuroablation for severe bradycardia due to sinus node dysfunction and/or atrioventricular nide dysfunction versus a sham procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06288633
Study type Interventional
Source Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Contact Aleksandr Vakhrushev, PhD
Phone +78127023749
Email advakhrushev@gmail.com
Status Recruiting
Phase N/A
Start date March 4, 2024
Completion date February 1, 2027
View Details
See also
  Status Clinical Trial Phase
Completed NCT03922386 - Safety and Electrical Performances of XFINE Leads N/A
Completed NCT03294018 - Heart Rate Changes Following the Administration of Sugammadex
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Not yet recruiting NCT05440071 - PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
Completed NCT02153242 - The Effects of Selective Site Right Ventricular Pacing
Recruiting NCT01825473 - Study of Erythromycin in GER-Associated Apnea of the Newborn N/A
Completed NCT00950287 - Detection of Neonatal Bradycardia N/A
Completed NCT00721136 - Randomized Study of the Use of Warfarin During Pacemaker or ICD Implantation in Patients Requiring Long Term Anticoagulation N/A
Completed NCT00286858 - Beluga - Clinical Observations of Automatic Algorithms for Cardiac Pacing
Completed NCT00158925 - The EASYTRAK EPI Clinical Investigation Phase 3
Completed NCT00180557 - Austria Study - Analysis of Difference Between Active and Passive Fixation Leads Phase 4
Completed NCT01076348 - Model 4965 Post-Approval Study
Completed NCT04198220 - BIO|STREAM.ICM Obesity
Recruiting NCT05298748 - The Effect of Womb Recordings on Maturation of Respiratory Control in Preterm Infants N/A
Recruiting NCT04353960 - The Alaska Oculocardiac Reflex Study
Terminated NCT04093414 - Left Bundle Area Versus Selective His Bundle Pacing N/A
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT04075084 - Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)