The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial fibrillation and flutter in routine clinical practice. The main questions it aims to answer are: * What is the incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal atrial fibrillation (AF)/atrial flutter (AFL) after the first dose of Refralon®? * What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®?
The registry is a retrospective multicenter observational study in patients with paroxysmal and persistent forms of AF and AFL who underwent chemical cardioversion with Refralon® in a hospital setting. After the compliance with the inclusion criteria and the absence of exclusion criteria based on medical documentation, the patient data will be collected from medical documentation available for the analysis into a unified electronic case report form (eCRF). Alongside the study therapy, all the patients must receive an adequate anticoagulant therapy in accordance with the current clinical guidelines of the Ministry of Health of the Russian Federation. After chemical cardioversion, patients were followed up and examined as a part of routine clinical practice. The examination data will be used for this study analysis. No additional therapeutic or diagnostic procedures are provided by the analysis protocol. Study patient follow-up period was 24 hours from the Refralon® first dose administration. The patients' data collection is planned for 8 months. It is planned to enroll 1500 patients with persistent and paroxysmal AF and AFL, meeting the inclusion/exclusion criteria. If necessary, it is possible to extend the registry data collection period to include the planned number of patients. Approximately in 3 and 6 months from the registry initiation (but not earlier than after the inclusion of 150 patients into the registry), an interim collected data analysis can be performed in order to preliminary assess the Refralon® efficacy and safety data in this study, as well as to identify the potential data entry errors.
Study Type
OBSERVATIONAL
Enrollment
1,147
1 mg/ml concentrate for solution for intravenous injection. (Prior to the administration, 2 mL of Refralon® must be diluted to 20 mL in 0.9 % sodium chloride).
Federal State Budgetary Educational Institution of Higher Education "Bashkir State Medical University" of the Ministry for Healthcare of the Russian Federation
Ufa, Bashkortostan Republic, Russia
State Budgetary Healthcare Institution of Republic of Bashkortostan "City Hospital Clinical Hospital № 21"
Ufa, Bashkortostan Republic, Russia
State Autonomous Healthcare Institution of the Kemerovo Region "Novokuznetsk City Clinical Hospital № 1"
Novokuznetsk, Kemerovo Oblast, Russia
State Budgetary Healthcare Institution of Sverdlovsk Region "Scientific-practical center of specialized typed of medical care "URAL INSTITUTE OF CARDIOLOGY"
Yekaterinburg, Sverdlovsk Oblast, Russia
"First Clinical Medical Center" LLC
Kovrov, Vladimirskaya Oblast’, Russia
Incidence of sinus rhythm restoration
Incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal AF/AFL after the first dose of Refralon®
Time frame: up to 6 hours
Incidence of sinus rhythm restoration
Incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®
Time frame: up to 24 hours
Time from the Refralon® administration start to the sinus rhythm restoration
Time frame: from Refralon® administration to the sinus rhythm restoration, up to 24 hours
Incidence of sinus rhythm maintenance
Incidence of sinus rhythm maintenance in patients 24 hours after the first Refralon® dose
Time frame: up to 24 hours
Incidence of AF/AFL sustained recurrences
Incidence of AF/AFL sustained (for more than 30 seconds) recurrences within 24 hours after the successful cardioversion with Refralon®
Time frame: up to 24 hours
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The Regional State Budgetary Healthcare Institution "St. Joseph Belgorod Regional Clinical Hospital"
Belgorod, Russia
State budgetary Healthcare Institution "Cardiological Dispensary"
Ivanovo, Russia
Federal State Budgetary Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Healthсare of the Russian Federation
Moscow, Russia
State Budgetary Healthcare Institution "City Clinical Hospital named after I.V. Davydovsky of Moscow Healthcare Department"
Moscow, Russia
Federal State Budgetary Institution "Clinical hospital № 1" administrative Department of the President of the Russian Federation
Moscow, Russia
...and 23 more locations