Clinical Trials Logo

Clinical Trial Summary

Patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation will be included in the study. We will determine the influence of pacemaker implantation with the localization of the ventricular electrode in the top of the right ventricle or the middle third of the right ventricle according to echocardiographic and electrocardiographic parameters, congestive heart failure progression, patients' quality of life and follow-up therapy of patients with identified myocardial fibrosis with existing pacemaker. Study of changes in echocardiography, electrocardiography, myocardial fibrosis markers, the quality of life of patients will allow to choose the most optimal localization of the ventricular electrode during implantation of the permanent pacemakers system in order to improve the quality of life of the patients.


Clinical Trial Description

Anticipated design of the study: an open, prospective, study, with parallel groups of patients according to ICH GCP ((International Conference on Harmonisation - Good Clinical Practice) criteria. The study will involve 300 patients with cardiac pathology and arrhythmias including those who have indications for pacemakers implantation, who will be allocated into 2 groups: group 1 - patients who require a permanent pacemaker placement; group 2 - patients who do not require a permanent pacemaker placement. Patients involved in the study will undergo peripheral venous blood sampling to determine the level of myocardial fibrosis markers (Halitin-3, ST2), electrocardiography (assessment of the type of bradyarrhythmia, assessment of the presence/absence and type of intraventricular conductivity disorder, estimation of the width of the QRS complex, direction of the electric axis of the heart), echocardiography (evaluation of ejection fraction, heart chamber size, mitral and tricuspidal manifestation, interventricular delay), contrast-enhanced cardiac magnetic resonance imaging (MRI), quality of life assessment using the Aquarel questionnaire. All procedures will be repeated at time points as per protocol. Specific information for Group A patients: there will be different variants of localization of the right ventricular lead (top of the right ventricle, the upper third of the ventricular septum, the middle third of the ventricular septum, the lower third of the ventricular septum, front wall of the right ventricle, lower wall of the right ventricle, parahisial region, His bundle). The analysis of the subgroups will be carried out according to the following criteria: electrode localization, main indication for pacemakers implantation, pacemakers model, type of initial intraventricular conductivity disorder. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05920226
Study type Observational
Source Ryazan State Medical University
Contact
Status Active, not recruiting
Phase
Start date July 1, 2023
Completion date July 1, 2028

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT04571385 - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF) Phase 2
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Completed NCT05366803 - Women's Health Initiative Silent Atrial Fibrillation Recording Study N/A
Completed NCT02864758 - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting NCT05442203 - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease N/A
Completed NCT05599308 - Evaluation of Blood Pressure Monitor With AFib Screening Feature N/A
Completed NCT03790917 - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation NCT05890274 - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO N/A
Recruiting NCT05266144 - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting NCT05316870 - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation N/A
Not yet recruiting NCT06023784 - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Recruiting NCT04092985 - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed NCT04087122 - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures N/A
Completed NCT06283654 - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting NCT05416086 - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed NCT04546763 - Study Watch AF Detection At Home
Completed NCT03761394 - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke N/A