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

Primary Purpose

Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke

Status
Unknown status
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Cardioversion
Oral Anticoagulant
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, conversion, stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Suleyman Demirel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transesophageal Echocardiography group

Oral anticoagulant Group

Arm Description

This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion

This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.

Outcomes

Primary Outcome Measures

Any clinical thromboembolic or hemorrhagic event, death or silent cerebral thromboemboli
Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion

Secondary Outcome Measures

Full Information

First Posted
August 7, 2013
Last Updated
March 17, 2021
Sponsor
Suleyman Demirel University
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1. Study Identification

Unique Protocol Identification Number
NCT01924065
Brief Title
Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation
Acronym
AFTER-CV
Official Title
Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 istead 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardioversion, Cerebrovascular Stroke
Keywords
Atrial fibrillation, conversion, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transesophageal Echocardiography group
Arm Type
Active Comparator
Arm Description
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Arm Title
Oral anticoagulant Group
Arm Type
Active Comparator
Arm Description
This arm includes the patients with atrial fibrillation who take warfarin or new oral anticoagulant agents three weeks before electrical cardioversion.
Intervention Type
Procedure
Intervention Name(s)
Cardioversion
Intervention Description
Electrical cardioversion
Intervention Type
Drug
Intervention Name(s)
Oral Anticoagulant
Intervention Description
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
Primary Outcome Measure Information:
Title
Any clinical thromboembolic or hemorrhagic event, death or silent cerebral thromboemboli
Description
Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Ozaydin, Professor,MD
Organizational Affiliation
Suleyman Demirel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suleyman Demirel University
City
Isparta
State/Province
Mediterranean Region
ZIP/Postal Code
32260
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

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