- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06151132
Treatment of Atrial Fibrillation in the Community Settings
November 21, 2023 updated by: Artemiy Okhotin, ITMO University
Description of treatment of cardiovascular diseases in community settings in Russia
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
430
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
People receiving treatment for atrial fibrillation in Tarusa hospital.
Description
Inclusion Criteria:
- all patients undergoing direct current cardioversion for atrial fibrillation or flutter
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with atrial fibrillation
Direct current cardioversion
|
Direct current cardioversion to maintain sinus rhythm during rhythm control strategy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Restoration of sinus rhythm
Time Frame: 1 day
|
Restoration of sinus rhythm during direct current cardioversion
|
1 day
|
|
Maintenance in rhythm control strategy
Time Frame: 7 years
|
Maintenance in rhythm control strategy during treatment of atrial fibrillation
|
7 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gender
Time Frame: During procedure
|
Gender
|
During procedure
|
|
Age
Time Frame: During procedure
|
Age
|
During procedure
|
|
Body mass index
Time Frame: During procedure
|
weight in kilograms divided by the square of height in meters
|
During procedure
|
|
Heart Failure
Time Frame: Before procedure
|
Past history of chronic heart failure
|
Before procedure
|
|
Arterial hypertension
Time Frame: Before procedure
|
Past history of arterial hypertension
|
Before procedure
|
|
Coronary heart disease
Time Frame: Before procedure
|
Past history of coronary heart disease
|
Before procedure
|
|
Diabetes mellitus
Time Frame: Before procedure
|
Past history of diabetes mellitus
|
Before procedure
|
|
Type of arrhythmia
Time Frame: During procedure
|
Atrial fibrillation or atrial flutter
|
During procedure
|
|
Duration of arrhythmia
Time Frame: Before procedure
|
Duration of episode of arrhythmia before cardioversion
|
Before procedure
|
|
Settings
Time Frame: During procedure
|
Whether procedure performed in inpatient or outpatient settings
|
During procedure
|
|
TEE
Time Frame: Before procedure
|
Whether transesophageal echocardiography was performed before procedure
|
Before procedure
|
|
First procedure
Time Frame: Before procedure
|
Whether it is the first cardioversion in the patient
|
Before procedure
|
|
Echo LVEF
Time Frame: During procedure
|
Left ventricular ejection fraction measured by echocardiography
|
During procedure
|
|
Echo LAVI
Time Frame: During procedure
|
Left atrium volume index measured by echocardiography
|
During procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
November 21, 2023
First Submitted That Met QC Criteria
November 21, 2023
First Posted (Actual)
November 30, 2023
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ITMOU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deposition of all anonymized data in public repository.
IPD Sharing Time Frame
With the publication, for 5 years.
IPD Sharing Access Criteria
Public domain.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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