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

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

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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