Ignite Creation Date:
2024-05-06 @ 6:46 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773170
Status:
COMPLETED
Last Update Posted:
2023-10-12
First Post:
2023-03-06
Brief Title:
Efficacy and Safety Evaluation of Refralon Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter
Sponsor:
R-Pharm
Organization:
R-Pharm
Study Overview
Official Title:
Retrospective Registry for the Efficacy and Safety Evaluation of Refralon Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 AFatrial flutter AFL after the first dose of Refralon
What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AFAFL after the first dose of Refralon
What is the incidence of sinus rhythm restoration within 6 hours in patients with paroxysmal atrial fibrillation AFatrial flutter AFL after the first dose of Refralon
What is the incidence of sinus rhythm restoration within 24 hours in patients with persistent AFAFL after the first dose of Refralon
Detailed Description:
The registry is a retrospective multicenter observational study in patients with paroxysmal and persistent forms of AF and AFL who underwent chemical cardioversion with Refralon in a hospital setting
After the compliance with the inclusion criteria and the absence of exclusion criteria based on medical documentation the patient data will be collected from medical documentation available for the analysis into a unified electronic case report form eCRF
Alongside the study therapy all the patients must receive an adequate anticoagulant therapy in accordance with the current clinical guidelines of the Ministry of Health of the Russian Federation After chemical cardioversion patients were followed up and examined as a part of routine clinical practice The examination data will be used for this study analysis No additional therapeutic or diagnostic procedures are provided by the analysis protocol
Study patient follow-up period was 24 hours from the Refralon first dose administration
The patients data collection is planned for 8 months It is planned to enroll 1500 patients with persistent and paroxysmal AF and AFL meeting the inclusionexclusion criteria If necessary it is possible to extend the registry data collection period to include the planned number of patients
Approximately in 3 and 6 months from the registry initiation but not earlier than after the inclusion of 150 patients into the registry an interim collected data analysis can be performed in order to preliminary assess the Refralon efficacy and safety data in this study as well as to identify the potential data entry errors
After the compliance with the inclusion criteria and the absence of exclusion criteria based on medical documentation the patient data will be collected from medical documentation available for the analysis into a unified electronic case report form eCRF
Alongside the study therapy all the patients must receive an adequate anticoagulant therapy in accordance with the current clinical guidelines of the Ministry of Health of the Russian Federation After chemical cardioversion patients were followed up and examined as a part of routine clinical practice The examination data will be used for this study analysis No additional therapeutic or diagnostic procedures are provided by the analysis protocol
Study patient follow-up period was 24 hours from the Refralon first dose administration
The patients data collection is planned for 8 months It is planned to enroll 1500 patients with persistent and paroxysmal AF and AFL meeting the inclusionexclusion criteria If necessary it is possible to extend the registry data collection period to include the planned number of patients
Approximately in 3 and 6 months from the registry initiation but not earlier than after the inclusion of 150 patients into the registry an interim collected data analysis can be performed in order to preliminary assess the Refralon efficacy and safety data in this study as well as to identify the potential data entry errors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None