Treatment of Atrial Fibrillation in the Community Settings

• Sponsor: ITMO University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06151132
• Collaborator: (none)
• Enrollment: 430
• Actual Duration (Months): 85.9

Study Details

Study Description

Brief Summary

Description of treatment of cardiovascular diseases in community settings in Russia

Condition or Disease	Intervention/Treatment	Phase
Atrial Arrhythmia; Cardiovascular Diseases	Procedure: Direct current cardioversion

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

• Study Type: Observational
• Actual Enrollment: 430 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Treatment of Atrial Fibrillation in the Community Settings
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2022
• Actual Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with atrial fibrillation Direct current cardioversion	Procedure: Direct current cardioversion; Direct current cardioversion to maintain sinus rhythm during rhythm control strategy

Outcome Measures

Primary Outcome Measures

1. Restoration of sinus rhythm [1 day]

   Restoration of sinus rhythm during direct current cardioversion

2. Maintenance in rhythm control strategy [7 years]

   Maintenance in rhythm control strategy during treatment of atrial fibrillation

Other Outcome Measures

1. Gender [During procedure]

   Gender

2. Age [During procedure]

   Age

3. Body mass index [During procedure]

   weight in kilograms divided by the square of height in meters

4. Heart Failure [Before procedure]

   Past history of chronic heart failure

5. Arterial hypertension [Before procedure]

   Past history of arterial hypertension

6. Coronary heart disease [Before procedure]

   Past history of coronary heart disease

7. Diabetes mellitus [Before procedure]

   Past history of diabetes mellitus

8. Type of arrhythmia [During procedure]

   Atrial fibrillation or atrial flutter

9. Duration of arrhythmia [Before procedure]

   Duration of episode of arrhythmia before cardioversion

10. Settings [During procedure]

    Whether procedure performed in inpatient or outpatient settings

11. TEE [Before procedure]

    Whether transesophageal echocardiography was performed before procedure

12. First procedure [Before procedure]

    Whether it is the first cardioversion in the patient

13. Echo LVEF [During procedure]

    Left ventricular ejection fraction measured by echocardiography

14. Echo LAVI [During procedure]

    Left atrium volume index measured by echocardiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• all patients undergoing direct current cardioversion for atrial fibrillation or flutter

Exclusion Criteria:

• none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ITMO University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Artemiy Okhotin, researcher in Digital Public Health Technologies, ITMO University
• ClinicalTrials.gov Identifier: NCT06151132
• Other Study ID Numbers: ITMOU
• First Posted: Nov 30, 2023
• Last Update Posted: Nov 30, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Atrial Fibrillation; Cardiovascular Diseases

Study Results

No Results Posted as of Nov 30, 2023