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OpenTrials
Completed

NCT Number: NCT01924065

Risk of Stroke and Silent Cerebrovascular Thromboembolism After Cardioversion of Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Cardioversion Central Nervous System Diseases Cerebrovascular Disorders Cerebrovascular Stroke Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Suleyman Demirel University

Isparta, Mediterranean Region, 32260, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 disabling 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

Treatment and study plan

Cardioversion

Procedure

Electrical cardioversion

Oral anticoagulant

Drug

warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage

Primary outcomes

  1. Combined Clinical Thromboembolic or Hemorrhagic Event, Death or Silent Cerebral Thromboemboli

    Time frame: 2 years

    Clinical events during 2 years follow-up or silent cerebral thromboemboli detected by diffusion magnetic resonance imaging at 1 week post-cardioversion

  2. Efficacy Clinical End-point

    Time frame: 2 years

    Any Clinical Thromboembolic Event, Death or Silent Cerebral Thromboemboli

  3. Ischemic Stroke/Transient Ischemic Attack

    Time frame: 2 years

  4. Acute Ischemia in MRI

    Time frame: 1 week

    Development of acute silent cerebral ischemia detected by MRI

  5. Mortality

    Time frame: 2 years

  6. Hemorrhagic Stroke

    Time frame: 2 years

  7. Gastrointestinal Bleeding

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Suleyman Demirel University

Other

Registry information

Official study title

Does Cardioversion of Atrial Fibrillation Increase the Risk of Stroke and Silent Cerebrovascular Thromboembolism? Comparison of the Two Cardioversion Methods

Acronym: AFTER-CV

Important dates

Study start
2013
Primary completion
2017
Study completion
2024
First posted
Aug 16, 2013
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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