NCT01924065CompletedPhase 3
Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation
Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods
Source: ClinicalTrials.gov · Last updated 15 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 112 (actual)
- First submitted
- 7 Aug 2013
- Start date
- 1 Aug 2013
- Primary completion date
- 31 Aug 2017
- Lead sponsor
- Suleyman Demirel University
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT01924065
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 112
- From 1 Aug 2013 to the primary completion date, 31 Aug 2017
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hematological disorders disabling patients to receive anticoagulant agents
- Serious rheumatic heart valve disease
- History of malignancy
Lab values
- Ejection fraction \< 0.25
Other
- Urgent cardioversion
- Patients who have implanted pace-makers or other metal devices
- Claustrophobia
- Atrial fibrillation secondary to temporary causes.
- Hyperthyroidism
- Left atrium diameter \> 55 mm
Who the study is looking for
- Patients with the age of more than 18 years who are planned to undergo electrical or medical cardioversion
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Suleyman Demirel University Coordinator of this site? Confirm its status | Isparta | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.