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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Suleyman Demirel University
Sponsor:
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University
ClinicalTrials.gov Identifier:
NCT01924065
First received: August 7, 2013
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

Patients with atrial fibrillation undergoing cardioversion will be randomized to undergo transesophageal echocardiography or they will receive warfarin for 4 weeks with an international normalized ratio (INR) value between 2.0-3.0.

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. 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 during this period will also be recorded.


Condition Intervention Phase
Atrial Fibrillation
Cardioversion
Cerebrovascular Stroke
Procedure: Cardioversion
Drug: warfarin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

Resource links provided by NLM:


Further study details as provided by Suleyman Demirel University:

Primary Outcome Measures:
  • Stroke [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    ischemic or hemorrhagic strokes will be recorded


Secondary Outcome Measures:
  • silent cerebral thromboemboli [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    silent cerebral thromboemboli detected by diffusion magnetic resonance imaging

  • bleeding [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    Any bleeding


Estimated Enrollment: 140
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Transesophageal Echocardiography group
This arm includes the patients with atrial fibrillation who undergo transesophageal echocardiography-guided cardioversion
Procedure: Cardioversion
Active Comparator: Warfarin Group
This arm includes the patients with atrial fibrillation who take warfarin four weeks before electrical cardioversion.
Procedure: Cardioversion Drug: warfarin

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Urgent cardioversion
  • Patients who have implanted pace-makers or other metal devices
  • Claustrophobia
  • Hematological disorders enabling 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924065

Locations
Turkey
Suleyman Demirel University Recruiting
Isparta, Mediterranean Region, Turkey, 32260
Contact: Abdullah Dogan, Proffesor,MD    +0902462324479 ext 1140    adogan35@hotmail.com   
Principal Investigator: Mehmet Ozaydin, Proffesor,MD         
Sub-Investigator: İbrahim Ersoy, MD         
Sponsors and Collaborators
Suleyman Demirel University
Investigators
Principal Investigator: Mehmet Ozaydin, Proffesor,MD Suleyman Demirel University
  More Information

No publications provided

Responsible Party: Mehmet Ozaydin, MD, MD, Professor in Cardiology, Suleyman Demirel University
ClinicalTrials.gov Identifier: NCT01924065     History of Changes
Other Study ID Numbers: ozaydin291
Study First Received: August 7, 2013
Last Updated: March 13, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Suleyman Demirel University:
Atrial fibrillation, conversion, stroke

Additional relevant MeSH terms:
Atrial Fibrillation
Stroke
Cerebral Infarction
Thromboembolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Embolism and Thrombosis
Thrombosis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014