Cardioneuroablation for Bradyarrhythmia
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
| Condition(s) | Bradycardia, Syncope, Sick Sinus Syndrome |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. 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 bradycardia with a rhythm frequency of \<30 beats/min. (1.3.) Transient atrioventricular block of II-III degree or permanent block of II degree. (1.4.) Repeated fainting or pre-fainting states with a proven association with bradycardia (without injury). (1.5.) Rhythm pauses \>6 seconds. In combination with the following two criteria: 2. 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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
| Locations | Saint Petersburg, Russia |
| Start date | 2024-03-04 |
| NCT ID | NCT06288633 |
| Official listing | https://clinicaltrials.gov/study/NCT06288633 |