Refralon in Patients With Recurrence Paroxysmal and Persistent Forms of Atrial Fibrillation and Atrial Flutter Who Underwent Catheter Ablation

• Status: Recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Criteria

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:

1. Arrhythmogenic effect of antiarrhythmic drugs III class in history;

2. Chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2;

3. Chronic heart failure (functional class IV);

4. Acute coronary syndrome;

5. Bronchial asthma of an uncontrolled course and / or severe respiratory failure.

6. The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal

7. Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);

8. Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);

9. Bradysystolic atrial fibrillation (heart rate <50 beats/min);

10. Duration of the QT interval >440 ms;

11. Hemodynamic instability requiring emergency cardioversion;

12. Contraindications to anticoagulant therapy;

13. Thyrotoxicosis or decompensated hypothyroidism;

14. Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);

15. Pregnancy and breastfeeding period.