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Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter

NCT05773170 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1147

Last updated 2023-10-12

No results posted yet for this study

Summary

The goal of this retrospective registry is to evaluate the efficacy and safety of Refralon®, concentrate for solution for intravenous injection, as chemical cardioversion in patients with paroxysmal and persistent atrial fibrillation and flutter in routine clinical practice. The main questions it aims to answer are:

* What is the incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal atrial fibrillation (AF)/atrial flutter (AFL) after the first dose of Refralon®?
* What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AF/AFL after the first dose of Refralon®?

Conditions

  • Paroxysmal Atrial Fibrillation
  • Persistent Atrial Fibrillation
  • Atrial Flutter

Interventions

DRUG

Refralon

1 mg/ml concentrate for solution for intravenous injection. (Prior to the administration, 2 mL of Refralon® must be diluted to 20 mL in 0.9 % sodium chloride).

Sponsors & Collaborators

  • FSBI "National Medical Research Center of Cardiology named after academician E.I.Chazov" of the Ministry of Health of the Russian Federation

    collaborator UNKNOWN

  • R-Pharm

    lead INDUSTRY

Principal Investigators

  • Mikhail Samsonov · Chief Medical Officer, R-Pharm

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05773170 on ClinicalTrials.gov