Atrium; FibrillationNCT05456204
Refralon in Patients With Recurrence Paroxysmal and Persistent Forms of Atrial Fibrillation Who Underwent Catheter Ablation
A study testing Pharmacological cardioversion with Refralon in people with Atrium; Fibrillation and Atrium; Flutter, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrium; Fibrillation, Atrium; Flutter
- What is being tested?
- Pharmacological cardioversion with Refralon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteRussia
- Study dates
- 15 Feb 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Arrhythmogenic effect of antiarrhythmic drugs III class in history;
- 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.
- The need for the use of drugs that increase the duration of the QT interval drugs without the possibility of withdrawal
Show all 15Show fewer
- 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);
- Bradysystolic atrial fibrillation (heart rate <50 beats/min);
- Duration of the QT interval >440 ms;
- Hemodynamic instability requiring emergency cardioversion;
- Contraindications to anticoagulant therapy;
- Thyrotoxicosis or decompensated hypothyroidism;
- Uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l);
- Pregnancy and breastfeeding period.
Trial locations and contacts
1 site in 1 country.
Russia1 site
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
Moscow, 121552
About this study
Official title: Efficacy and Safety of Refralon in Patients With Recurrent Atrial Fibrillation and Atrial Flutter After Catheter Ablation.
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.
Read the detailed description
Atrial fibrillation and atrial flutter are the most common arrhythmias among the adult population of the world, their share in the population is from 2 to 4% and continues to grow.
Modern highly effective methods of minimally invasive surgical treatment of these types of arrhythmia are currently catheter radiofrequency ablation and balloon cryoablation of the pulmonary veins. According to the CABANA study, catheter interventions reduce the risk of recurrent AF/AFL by 47%, significantly improving arrhythmia tolerance and improving the quality of life of patients.
An important problem is the recurrence of arrhythmia after the intervention, the frequency of recurrence of AF/AFL in the first 3 months after ablation (the so-called early recurrence) is 50-60%. In many patients, these recurrence are accompanied by severe clinical manifestations, which require pharmacological or electrical cardioversion.
In order to restore sinus rhythm, electrical cardioversion is most often used, the effectiveness of which is 90-92%.
An alternative to electrical cardioversion is pharmacological cardioversion, however, antiarrhythmic drugs used in wide clinical practice can restore sinus rhytm (SR) only in patients with recent AF paroxysms.
In 2014, a new Russian class III antiarrhythmic drug, Refralon, was registered. The effectiveness of the Refralon as a means of cardioversion in patients with persistent AF/AFL is 90%, in patients with paroxysmal AF/AFL - 95%.
At present, there is no information on the efficacy and safety of the use of refralon in patients with AF / AFL who underwent catheter ablation. The growing number of catheter ablation in the world dictates the to study new approaches to performing cardioversion in this cohort of patients.
- Conditions
- Atrium; Fibrillation, Atrium; Flutter
- Being tested
- Pharmacological cardioversion with Refralon
- Keywords
- atrial fibrillation and flutter, paroxysmal and persistent atrial fibrillation and flutter, cardioversion AF, catheter radiofrequency ablation, Refralon, Niferidil, new antiarrhythmic drug, balloon cryoablation, reccurrence atrial fibrillation and flutter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacological cardioversion with RefralonDrug
Also called Refralone
- the introduction of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight, diluted in 20 ml of saline intravenously for 2-3 minutes;
- in the absence of effect (SR recovery did not occur), after 15 minutes,repeated intravenous administration of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight (total dose of the drug 10 μg / kg of body weight);
- in the absence of effect (SR recovery did not occur),after 15 minutes, the next intravenous injection of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight (total dose of the drug 20 μg / kg of body weight);
- in the absence of effect (recovery of SR did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight. Thus, the maximum total dose of the drug will be 30 μg/kg of body weight.
| Study group | Role | What they receive |
|---|---|---|
| Refralone group | Other | Patients with recurrent AF/AFL after catheter interventions to restore SR will be cardioverted with refralon Receives: Drug: Pharmacological cardioversion with Refralon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of sinus rhythm
Restoration of SR within 24 hours from the moment of administration of the first dose of refraloRestoration of SR within 24 hours from the moment of administration of the first dose of refralon
Measured: 24 hour
Preservation of SR
Preservation of SR 24 hours after the first dose of refralon.
Measured: 24 hours
Ventricular arrhythmogenic effect
Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug
Measured: 24 hours
Increased QT interval (more than 500 ms)
The number of patients who have an increase in the QT interval (more than 500 ms) and the time during which the duration of the QT interval exceeded 500 ms.
Measured: 24 hours
Secondary outcomes (5)
Restoration of sinus rhythm within 6 hours
Restoration of SR within 6 hours from the moment of administration of the first dose of refralon
Measured: 6 hours
Number of patients recovering SR after minimal doses
Number of patients who recovered SR after minimal doses of refralon (5-10 μg/kg)
Measured: 24 hours
Reccurence after SR recovery
Absence of sustained (lasting more than 30 seconds) recurrences of AF/AFL within 24 hours after successful recovery of SR with refralon
Measured: 24 hours
Bradyarrhythmias (pauses and bradycardia)
Decrease in heart rate to less than 50bpm after administration of drug (refralon/amiodarone) during AF or after restoration of SR - the minimum heart rate, the duration of the maximum recorded pause and the time during which the heart rate was less than 50bpm will be recorded
Measured: 24 hours
Pauses more than 5 seconds
The presence of pauses for more than 5 seconds at the time of SR recovery or against the background of persistent AF/AT.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start15 Feb 2022
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrium; FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456204
- Sponsor's protocol ID
- JCBY-2021-0007-288
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Refralon in Patients With Recurrent Atrial Fibrillation and Atrial Flutter After Catheter Ablation.
- ClinicalTrials.gov ID
- NCT05456204
- Acronym / sponsor ID
- JCBY-2021-0007-288
- Conditions
- Atrium; Fibrillation, Atrium; Flutter
- Keywords
- atrial fibrillation and flutter, paroxysmal and persistent atrial fibrillation and flutter, cardioversion AF, catheter radiofrequency ablation, Refralon, Niferidil, new antiarrhythmic drug, balloon cryoablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian FederationOther government
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Atrial fibrillation and atrial flutter are the most common arrhythmias among the adult population of the world, their share in the population is from 2 to 4% and continues to grow.
Modern highly effective methods of minimally invasive surgical treatment of these types of arrhythmia are currently catheter radiofrequency ablation and balloon cryoablation of the pulmonary veins. According to the CABANA study, catheter interventions reduce the risk of recurrent AF/AFL by 47%, significantly improving arrhythmia tolerance and improving the quality of life of patients.
An important problem is the recurrence of arrhythmia after the intervention, the frequency of recurrence of AF/AFL in the first 3 months after ablation (the so-called early recurrence) is 50-60%. In many patients, these recurrence are accompanied by severe clinical manifestations, which require pharmacological or electrical cardioversion.
In order to restore sinus rhythm, electrical cardioversion is most often used, the effectiveness of which is 90-92%.
An alternative to electrical cardioversion is pharmacological cardioversion, however, antiarrhythmic drugs used in wide clinical practice can restore sinus rhytm (SR) only in patients with recent AF paroxysms.
In 2014, a new Russian class III antiarrhythmic drug, Refralon, was registered. The effectiveness of the Refralon as a means of cardioversion in patients with persistent AF/AFL is 90%, in patients with paroxysmal AF/AFL - 95%.
At present, there is no information on the efficacy and safety of the use of refralon in patients with AF / AFL who underwent catheter ablation. The growing number of catheter ablation in the world dictates the to study new approaches to performing cardioversion in this cohort of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Refralone group | Other | Drug: Pharmacological cardioversion with RefralonPatients with recurrent AF/AFL after catheter interventions to restore SR will be cardioverted with refralon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- Arrhythmogenic effect of antiarrhythmic drugs III class in history;
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacological cardioversion with RefralonAlso: Refralone1. the introduction of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight, diluted in 20 ml of saline intravenously for 2-3 minutes; 2. in the absence of effect (SR recovery did not occur), after 15 minutes,repeated intravenous administration of a 0.1% solution of refralon at a dose of 5 μg per 1 kg of body weight (total dose of the drug 10 μg / kg of body weight); 3. in the absence of effect (SR recovery did not occur),after 15 minutes, the next intravenous injection of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight (total dose of the drug 20 μg / kg of body weight); 4. in the absence of effect (recovery of SR did not occur), after 15 minutes, repeated intravenous administration of a 0.1% solution of refralon at a dose of 10 μg per 1 kg of body weight. Thus, the maximum total dose of the drug will be 30 μg/kg of body weight. | Drug | Refralone group |
Primary outcome
Restoration of sinus rhythm
Time frame: 24 hour
Restoration of SR within 24 hours from the moment of administration of the first dose of refraloRestoration of SR within 24 hours from the moment of administration of the first dose of refralon
Preservation of SR
Time frame: 24 hours
Preservation of SR 24 hours after the first dose of refralon.
Ventricular arrhythmogenic effect
Time frame: 24 hours
Registration of sustained and nonsustained (3 or more QRS) ventricular tachycardia or ventricular fibrillation after administration of drug
Increased QT interval (more than 500 ms)
Time frame: 24 hours
The number of patients who have an increase in the QT interval (more than 500 ms) and the time during which the duration of the QT interval exceeded 500 ms.
5 secondary outcomes
Restoration of sinus rhythm within 6 hours
Time frame: 6 hours
Number of patients recovering SR after minimal doses
Time frame: 24 hours
Reccurence after SR recovery
Time frame: 24 hours
Bradyarrhythmias (pauses and bradycardia)
Time frame: 24 hours
Pauses more than 5 seconds
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacological cardioversion with Refralon in people with Atrium; Fibrillation and Atrium; Flutter, run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of sinus rhythm (time frame: 24 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.