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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Suleyman Demirel University
Coordinator of this site? Confirm its status
IspartaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.