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It is planned to evaluate the efficacy and safety of the class III antiarrhythmic drug refralon as a drug for pharmacological cardioversion in patients with recurrent atrial fibrillation (AF) and atrial flutter (AFL) after catheter ablation.
Atrial fibrillation and atrial flutter are the most common arrhythmias among the adult population of the world, their share in the population is from 2 to 4% and continues to grow.
Modern highly effective methods of minimally invasive surgical treatment of these types of arrhythmia are currently catheter radiofrequency ablation and balloon cryoablation of the pulmonary veins. According to the CABANA study, catheter interventions reduce the risk of recurrent AF/AFL by 47%, significantly improving arrhythmia tolerance and improving the quality of life of patients.
An important problem is the recurrence of arrhythmia after the intervention, the frequency of recurrence of AF/AFL in the first 3 months after ablation (the so-called early recurrence) is 50-60%. In many patients, these recurrence are accompanied by severe clinical manifestations, which require pharmacological or electrical cardioversion.
In order to restore sinus rhythm, electrical cardioversion is most often used, the effectiveness of which is 90-92%.
An alternative to electrical cardioversion is pharmacological cardioversion, however, antiarrhythmic drugs used in wide clinical practice can restore sinus rhytm (SR) only in patients with recent AF paroxysms.
In 2014, a new Russian class III antiarrhythmic drug, Refralon, was registered. The effectiveness of the Refralon as a means of cardioversion in patients with persistent AF/AFL is 90%, in patients with paroxysmal AF/AFL - 95%.
At present, there is no information on the efficacy and safety of the use of refralon in patients with AF / AFL who underwent catheter ablation. The growing number of catheter ablation in the world dictates the to study new approaches to performing cardioversion in this cohort of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refralone group | Other | Patients with recurrent AF/AFL after catheter interventions to restore SR will be cardioverted with refralon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacological cardioversion with Refralon | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of sinus rhythm | Restoration of SR within 24 hours from the moment of administration of the first dose of refraloRestoration of SR within 24 hours from the moment of administration of the first dose of refralon | 24 hour |
| Preservation of SR | Preservation of SR 24 hours after the first dose of refralon. | 24 hours |
| Ventricular arrhythmogenic effect | Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug | 24 hours |
| Increased QT interval (more than 500 ms) | The number of patients who have an increase in the QT interval (more than 500 ms) and the time during which the duration of the QT interval exceeded 500 ms. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration of sinus rhythm within 6 hours | Restoration of SR within 6 hours from the moment of administration of the first dose of refralon | 6 hours |
| Number of patients recovering SR after minimal doses |
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Inclusion Criteria:
2. Patients with paroxysmal or persistent forms of AF/AFL and early (less than 90 days) or late (more than 90 days) arrhythmia recurrence after catheter radiofrequency ablation or balloon cryoablation of pulmonary veins.
3. Indications for SR recovery. 4. Consent of the patient.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution NATIONAL MEDICAL RESEARCH CENTRE OF CARDIOLOGY NAMED AFTER ACADEMICIAN E.I.CHAZOV. of the Ministry of Health of the Russian Federation | Moscow | 121552 | Russia |
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|
|
Number of patients who recovered SR after minimal doses of refralon (5-10 μg/kg)
| 24 hours |
| Reccurence after SR recovery | Absence of sustained (lasting more than 30 seconds) recurrences of AF/AFL within 24 hours after successful recovery of SR with refralon | 24 hours |
| Bradyarrhythmias (pauses and bradycardia) | Decrease in heart rate to less than 50bpm after administration of drug (refralon/amiodarone) during AF or after restoration of SR - the minimum heart rate, the duration of the maximum recorded pause and the time during which the heart rate was less than 50bpm will be recorded | 24 hours |
| Pauses more than 5 seconds | The presence of pauses for more than 5 seconds at the time of SR recovery or against the background of persistent AF/AT. | 24 hours |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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