Retrospective Registry for the Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter

CC01897112

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®?

2022-11-11

2023-06-01

2023-06-01

Completed

1147

Inclusion Criteria: * Diagnosis: paroxysmal or persistent atrial fibrillation or flutter; * A chemical cardioversion procedure performed with Refralon® in a hospital setting. Exclusion Criteria: * Congenital or acquired QT interval prolongation in the electrocardiogram (ECG) in 12 standard leads for more than 440 ms at the time of cardioversion; * Bradysystolic atrial fibrillation or flutter (mean heart rate \< 50 bpm or pauses \> 3 sec, registered on the ECG or identified by the results of 24-hour Holter ECG monitoring, except for the cases of its correction by a cardiac pacemaker at the time of cardioversion; * Sick sinus syndrome (sinus bradycardia, sinoatrial blockade), previously registered as associated with sinus rhythm, except for the cases of its correction with a cardiac pacemaker at the time of cardioversion; * Degree II - III atrioventricular blockade, two- and three-beam blockade with no cardiac pacemaker at the time of cardioversion; * Acute myocardial infarction period at the time of cardioversion; * Acute period after coronary artery bypass grafting (CABG) or other cardiac surgery (at least 7 days after CABG at the time of cardioversion); * Decompensated or severe chronic heart failure (III-IV functional class according to New York Heart Association (NYHA) classification) at the time of cardioversion; * Uncontrolled bronchial asthma, severe respiratory failure at the time of cardioversion; * Pregnancy and breastfeeding at the time of cardioversion; * Administration of Class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide, procainamide) at the time of cardioversion; * Class III antiarrhythmic drugs administration at the time of cardioversion; * Cardiac glycosides administration at the time of cardioversion; * Administration of QT-prolonging drugs at the time of cardioversion; * Heart rate \< 50 bpm, pauses \> 3 seconds on the ECG or Holter ECG monitoring (HM-ECG) during wakefulness at the time of cardioversion; * Hyperthyroidism or decompensated hypothyroidism (thyroid stimulating hormone (TSH) \< lower limit of normal or \> 2 upper limits of normal) at the time of cardioversion; * Uncorrectable electrolyte disorders (potassium level less than 3.5 mmol/L) at the time of cardioversion; * Identified contraindications to the sinus rhythm restoration at the time of cardioversion; * Blood clots in the heart cavities or spontaneous grade III-IV echo contrast at the time of cardioversion according to transesophageal echocardiography; * The need for electrical cardioversion due to the patient's hemodynamic instability at the time of cardioversion.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1147, 'type': 'ACTUAL'}}

2023-10-12