Atrial ArrhythmiaNCT06151132
Treatment of Atrial Fibrillation in the Community Settings
An observational study of Atrial Arrhythmia and Cardiovascular Diseases, run by ITMO University.
Trial summary
Description of treatment of cardiovascular diseases in community settings in Russia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Arrhythmia, Cardiovascular Diseases
- What is being tested?
- Direct current cardioversion
- Type of treatment
- Surgery or procedure
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2023
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People receiving treatment for atrial fibrillation in Tarusa hospital.
Who may be able to join
- all patients undergoing direct current cardioversion for atrial fibrillation or flutter
Who cannot join
- none
About this study
Description of treatment of cardiovascular diseases in community settings in Russia
Read the detailed description
The study will describe different treatment modalities used in management of cardiovascular diseases in community hospital in small town of Tarusa in Russia. This part of the study will focus on atrial fibrillation and its treatment.
- Conditions
- Atrial Arrhythmia, Cardiovascular Diseases
- Being tested
- Direct current cardioversion
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct current cardioversionProcedure or surgery
Direct current cardioversion to maintain sinus rhythm during rhythm control strategy
| Study group | Role | What they receive |
|---|---|---|
| Patients with atrial fibrillation | Direct current cardioversion Receives: Procedure: Direct current cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of sinus rhythm
Restoration of sinus rhythm during direct current cardioversion
Measured: 1 day
Maintenance in rhythm control strategy
Maintenance in rhythm control strategy during treatment of atrial fibrillation
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2016
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial ArrhythmiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITMO University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artemiy Okhotin, ITMO University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151132
- Sponsor's protocol ID
- ITMOU
- Status last verified
- Nov 2023
- First submitted
- 21 Nov 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deposition of all anonymized data in public repository.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Atrial Fibrillation in the Community Settings
- ClinicalTrials.gov ID
- NCT06151132
- Acronym / sponsor ID
- ITMOU
- Conditions
- Atrial Arrhythmia, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- ITMO UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Nov 2023 (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.
Description of treatment of cardiovascular diseases in community settings in Russia
Detailed description
The study will describe different treatment modalities used in management of cardiovascular diseases in community hospital in small town of Tarusa in Russia. This part of the study will focus on atrial fibrillation and its treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with atrial fibrillation | – | Procedure: Direct current cardioversionDirect current cardioversion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People receiving treatment for atrial fibrillation in Tarusa hospital.
Key inclusion criteria (1 listed)
- all patients undergoing direct current cardioversion for atrial fibrillation or flutter
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Direct current cardioversionDirect current cardioversion to maintain sinus rhythm during rhythm control strategy | Procedure or surgery | Patients with atrial fibrillation |
Primary outcome
Restoration of sinus rhythm
Time frame: 1 day
Restoration of sinus rhythm during direct current cardioversion
Maintenance in rhythm control strategy
Time frame: 7 years
Maintenance in rhythm control strategy during treatment of atrial fibrillation
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 30 Nov 2023.
- Individual participant dataSharing planned: Yes. Deposition of all anonymized data in public repository.
Related trials for Atrial Arrhythmia
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Recruiting
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RecruitingPhase 2
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RecruitingPhase 3
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Arrhythmia and Cardiovascular Diseases, run by ITMO University.
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 1 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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: 1 day). The study lists 2 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 30 Nov 2023.