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Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation (AFTER-CV)
This study is ongoing, but not recruiting participants.
Sponsor:
Suleyman Demirel University
Information provided by (Responsible Party):
Mehmet Ozaydin, MD, Suleyman Demirel University
ClinicalTrials.gov Identifier:
NCT01924065
First received: August 7, 2013
Last updated: January 18, 2017
Last verified: January 2017
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Purpose
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 during this period will also be recorded.
| Condition | Intervention | Phase |
|---|---|---|
| Atrial Fibrillation Cardioversion Cerebrovascular Stroke | Procedure: Cardioversion Drug: Oral Anticoagulant | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 Mehmet Ozaydin, MD, Suleyman Demirel University:
Primary Outcome Measures:
- Ischemic stroke or silent cerebral thromboemboli [ Time Frame: 1 week ]clinical events or cerebral thromboemboli detected by diffusion magnetic resonance imaging
Secondary Outcome Measures:
- bleeding [ Time Frame: 1 week ]Any bleeding
- Clinical thromboembolic events [ Time Frame: 1 week ]
- Any clinical thromboembolic or hemorrhagic event [ Time Frame: 1 month ]
| Enrollment: | 108 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | June 2017 |
| Primary Completion Date: | August 2016 (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
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01924065
Please refer to this study by its ClinicalTrials.gov identifier: NCT01924065
Locations
| Turkey | |
| Suleyman Demirel University | |
| Isparta, Mediterranean Region, Turkey, 32260 | |
Sponsors and Collaborators
Suleyman Demirel University
Investigators
| Principal Investigator: | Mehmet Ozaydin, Professor,MD | Suleyman Demirel University |
More Information
| 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: | January 18, 2017 |
Keywords provided by Mehmet Ozaydin, MD, Suleyman Demirel University:
|
Atrial fibrillation, conversion, stroke |
Additional relevant MeSH terms:
|
Stroke Atrial Fibrillation Thromboembolism Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Vascular Diseases Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes Embolism and Thrombosis Anticoagulants |
ClinicalTrials.gov processed this record on July 24, 2017