protocolSection identificationModule nctId: NCT06288633, orgStudyIdInfo id: FNWMRC, briefTitle: Cardioneuroablation for Bradyarrhythmia, acronym: CARDIOBOOST, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, class: OTHER, collaborators name: Meshalkin National Medical Research Center, Ministry of Health of Russian Federation, collaborators name: The Federal Centre of Cardiovascular Surgery, Russia, collaborators name: Clinical City Hospital named after I.V. Davydovsky of Moscow Department of Healthcare, collaborators name: City Clinical Hospital No.52 of Moscow Healthcare Department, collaborators name: National Medical Research Center for Therapy and Preventive Medicine, collaborators name: Medical Centre Hospital of the President's Affairs Administration, Republic of Kazakhstan, collaborators name: Tomsk National Research Medical Center of the Russian Academy of Sciences, collaborators name: Vishnevsky Center of Surgery, collaborators name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation, descriptionModule briefSummary: 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, conditionsModule conditions: Bradycardia, conditions: Syncope, conditions: Sick Sinus Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 106, type: ESTIMATED, armsInterventionsModule interventions name: Ganglionated plexi ablation, interventions name: Electrophysiological study, outcomesModule primaryOutcomes measure: Implantation of a permanent cardiac pacemaker, secondaryOutcomes measure: Complications of cardioneuroablation, secondaryOutcomes measure: Presence of symptomatic or asymptomatic rhythm pauses >6 seconds, secondaryOutcomes measure: The presence of symptomatic or asymptomatic sinus bradycardia with an average heart rate <40 beats/min in the daytime, secondaryOutcomes measure: Transient or permanent atrioventricular block, secondaryOutcomes measure: Orthostatic hypotension and/or bradycardia during passive orthostasis test, secondaryOutcomes measure: Sinus tachycardia after cardioneuroablation, secondaryOutcomes measure: Implantation of a pacemaker by 24 months after randomization, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Almazov National Medical Research Centre, status: RECRUITING, city: Saint Petersburg, country: Russian Federation, contacts name: Shlyakhto, role: CONTACT, phone: +78127023749, geoPoint lat: 59.93863, lon: 30.31413, hasResults: False