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

CompletedOBSERVATIONAL
Enrollment

1,147

Participants

Timeline

Start Date

November 11, 2022

Primary Completion Date

June 1, 2023

Study Completion Date

June 1, 2023

Conditions
Paroxysmal Atrial FibrillationPersistent Atrial FibrillationAtrial 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).

Trial Locations (33)

101990

"Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation", Moscow

109240

"State Budgetary Healthcare Institution City Clinical Hospital named after I.V. Davydovsky of Moscow Healthcare Department", Moscow

121352

"Federal State Budgetary Institution Clinical hospital № 1 administrative Department of the President of the Russian Federation", Moscow

121552

"Federal State Budget Institution A.N. Bakulev National Medical Research Center of Cardiovascular Surgery of the Ministry of Health of the Russian Federation", Moscow

150062

"The State Budgetary Health Care Institution of the Yaroslavl Region Regional Clinical Hospital", Yaroslavl

153012

"State budgetary Healthcare Institution Cardiological Dispensary", Ivanovo

160002

"Budget Healthcare Institution of the Vologda Region Vologda Regional Clinical Hospital", Vologda

170036

"The State Budgetary Healthcare Institution of the Tver region Regional Clinical Hospital", Tver'

193079

"St. Petersburg State Budgetary Healthcare Institution Hospital for War Veterans", Saint Petersburg

197341

"Federal State Budgetary Institution National Medical Research Center (NMIC) named after V. A. Almazov Ministry of Health Russia", Saint Petersburg

197706

The Saint Petersburg State Health Care Establishment the City Hospital № 40 of the Resort District, Saint Petersburg

300065

State health institution City Hospital № 13 Tula (Tula regional cardiological dispensary), Tula

308007

"The Regional State Budgetary Healthcare Institution St. Joseph Belgorod Regional Clinical Hospital", Belgorod

390026

"State Budgetary Institution of the Ryazan region Regional Clinical Cardiology Dispensary", Ryazan

393760

"Tambov Regional State Budgetary Healthcare Institution S.S. Bryukhonenko City Hospital of Michurinsk", Tambov

394066

"The State Healthcare Institution Voronezh Regional Hospital № 1", Voronezh

400008

"The State Budgetary Healthcare Institution Volgograd Regional Clinical Cardiology Center", Volgograd

410039

"State Health Care Institution Regional Cardiology Clinic", Saratov

443070

"The State Budgetary Healthcare Institution of the Samara Region Samara Regional Clinical Cardiology Dispensary named after V.P. Polyakov", Samara

443096

Samara City Clinical Hospital № 1 named after N.I. Pirogov, Samara

450059

"Federal State Budgetary Educational Institution of Higher Education Bashkir State Medical University of the Ministry for Healthcare of the Russian Federation", Ufa

450071

"State Budgetary Healthcare Institution of Republic of Bashkortostan City Hospital Clinical Hospital № 21", Ufa

600020

"The State Budgetary Healthcare Institution of the Vladimir Region State Hospital № 4", Vladimir

601911

"First Clinical Medical Center LLC", Kovrov

614002

"State Budgetary Healthcare Institution of the Perm Region Clinical Cardiological Dispensary", Perm

620063

"State Budgetary Healthcare Institution of Sverdlovsk Region Scientific-practical center of specialized typed of medical care URAL INSTITUTE OF CARDIOLOGY", Yekaterinburg

630047

"State Budgetary Healthcare Institution of the Novosibirsk Region Novosibirsk Regional Clinical Cardiology Dispensary", Novosibirsk

630051

"State Budgetary Healthcare Institution of the Novosibirsk region City Clinical Hospital № 2", Novosibirsk

634012

"Cardiology Research Institute, Federal State Budgetary Scientific Institution Tomsk National Research Medical Center of the Russian Academy of Sciences", Tomsk

644018

Clinical Health Unit No. 9, Omsk

654057

"State Autonomous Healthcare Institution of the Kemerovo Region Novokuznetsk City Clinical Hospital № 1", Novokuznetsk

690034

"State Budgetary Healthcare Institution Sakhalin Regional Clinical Hospital", Yuzhno-Sakhalinsk

693010

"State Budgetary Healthcare Institution of the Sakhalin region Yuzhno-Sakhalinsk City Hospital named after F.S. Ankudinov", Yuzhno-Sakhalinsk

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

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

UNKNOWN

lead

R-Pharm

INDUSTRY

NCT05773170 - Efficacy and Safety Evaluation of Refralon®, Concentrate for Solution for Intravenous Injection in Patients With Paroxysmal and Persistent Atrial Fibrillation and Flutter | Biotech Hunter | Biotech Hunter