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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite 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
MoscowRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.