Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation (AFTER-CV)

October 29, 2024 updated by: Mehmet Ozaydin, MD, Suleyman Demirel University

Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 3 weeks with an international normalized ratio (INR) value between 2.0-3.0. Those who do not want to use warfarin will be given an approved new oral anticoagulant agent instead of warfarin for 3 weeks.

If thrombus is detected in left atrium or in left atrial appendage, no cardioversion will be performed. Other patients in the both groups will undergo electrical cardioversion. After the procedures all the patients will be given oral anticoagulant for at least 4 Weeks. All patients will have neurological examination and diffusion magnetic resonance imaging (MRI) at baseline and at postprocedural 7th day. Clinical and subclinical cerebral thromboembolic events detected by diffusion MRI will be recorded. Any bleeding events will also be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Mediterranean Region
      • Isparta, Mediterranean Region, Turkey, 32260
        • Suleyman Demirel University

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion

Exclusion Criteria:

  • Urgent cardioversion
  • Patients who have implanted pace-makers or other metal devices
  • Claustrophobia
  • Hematological disorders disabling patients to receive anticoagulant agents
  • Atrial fibrillation secondary to temporary causes.
  • Serious rheumatic heart valve disease
  • Hyperthyroidism
  • History of malignancy
  • Left atrium diameter > 55 mm
  • Ejection fraction < 0.25

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transesophageal Echocardiography group
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Procedure: Cardioversion
Electrical cardioversion
Active Comparator: Oral anticoagulant Group
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Procedure: Cardioversion
Electrical cardioversion
Drug: Oral Anticoagulant
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 2 years
2 years
Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli
Time Frame: 2 years
Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
2 years
Efficacy Clinical End-point
Time Frame: 2 years
Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli
2 years
Ischemic Stroke/Transient Ischemic Attack
Time Frame: 2 years
2 years
Acute Ischemia in MRI
Time Frame: 1 week
Development of acute silent cerebral ischemia detected by MRI
1 week
Hemorrhagic Stroke
Time Frame: 2 years
2 years
Gastrointestinal Bleeding
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleyman Demirel University

Investigators

  • Principal Investigator: Mehmet Ozaydin, Professor,MD, Suleyman Demirel University

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

August 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

October 29, 2024

Study Registration Dates

First Submitted

August 7, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimated)

August 16, 2013

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ozaydin291

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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