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 April 2016 by Suleyman Demirel University
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: April 19, 2016
Last verified: April 2016
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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.
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: | 120 |
| Study Start Date: | August 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated 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 or medical cardioversion and spontaneous sinus rhythm return
|
|
Active Comparator: Warfarin Group
This arm includes the patients with atrial fibrillation who take warfarin or oral anticoagulant agents four weeks before electrical cardioversion.
|
Procedure: Cardioversion
Electrical or medical cardioversion and spontaneous sinus rhythm return
Drug: warfarin
warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| 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 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
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
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
| 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: | April 19, 2016 |
| Health Authority: | Turkey: Ethics Committee |
Keywords provided by 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 Warfarin Anticoagulants |
ClinicalTrials.gov processed this record on September 29, 2016