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

NCT ID: NCT05456204

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-06-30

Brief 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.

Detailed Description

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.

Conditions

Atrium; Fibrillation; Atrium; Flutter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Refralone group

Patients with recurrent AF/AFL after catheter interventions to restore SR will be cardioverted with refralon

Group Type: OTHER

Pharmacological cardioversion with Refralon

Intervention Type: DRUG

1. the introduction of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight, diluted in 20 ml of saline intravenously for 2-3 minutes;

2. in the absence of effect (SR recovery did not occur), after 15 minutes,repeated intravenous administration of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight (total dose of the drug 10 μg / kg of body weight);

3. in the absence of effect (SR recovery did not occur),after 15 minutes, the next intravenous injection of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight (total dose of the drug 20 μg / kg of body weight);

4. in the absence of effect (recovery of SR did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight. Thus, the maximum total dose of the drug will be 30 μg/kg of body weight.

Interventions

Pharmacological cardioversion with Refralon

1. the introduction of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight, diluted in 20 ml of saline intravenously for 2-3 minutes;

2. in the absence of effect (SR recovery did not occur), after 15 minutes,repeated intravenous administration of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight (total dose of the drug 10 μg / kg of body weight);

3. in the absence of effect (SR recovery did not occur),after 15 minutes, the next intravenous injection of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight (total dose of the drug 20 μg / kg of body weight);

4. in the absence of effect (recovery of SR did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight. Thus, the maximum total dose of the drug will be 30 μg/kg of body weight.

Intervention Type: DRUG

Other Intervention Names

Refralone

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , Russia

Countries

Russia

Other Identifiers

JCBY-2021-0007-288

Identifier Type: -

Identifier Source: org_study_id