NCT05456204Completed
Refralon in Patients With Recurrence Paroxysmal and Persistent Forms of Atrial Fibrillation Who Underwent Catheter Ablation
Efficacy and Safety of Refralon in Patients With Recurrent Atrial Fibrillation and Atrial Flutter After Catheter Ablation.
Source: ClinicalTrials.gov · Last updated 27 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 120 (actual)
- First submitted
- 11 Jul 2022
- Start date
- 15 Feb 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Diseases
- Atrial fibrillation
- NCT number
- NCT05456204
What you commit to
- Study type: Interventional
- Participants enrolled: 120
- From 15 Feb 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Arrhythmogenic effect of antiarrhythmic drugs III class in history;
- Contraindications to anticoagulant therapy;
Other illness
- Chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2;
- Chronic heart failure (functional class IV);
- Acute coronary syndrome;
- Bronchial asthma of an uncontrolled course and / or severe respiratory failure.
- Bradysystolic atrial fibrillation (heart rate \<50 beats/min);
Lab values
- The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal
- Duration of the QT interval \>440 ms;
- Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);
Other
- Atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker);
- Dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker);
- Hemodynamic instability requiring emergency cardioversion;
- Thyrotoxicosis or decompensated hypothyroidism;
- Pregnancy and breastfeeding period.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 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 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.