Status:

NOT_YET_RECRUITING

D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation: A Multicenter Belgian Study

Lead Sponsor:

AZ Sint-Jan AV

Conditions:

Atrial Fibrillation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This trial aims at evaluating the number of thromboembolic events post cardioversion in patients receiving a direct current cardioversion with either prior transesophageal echocardiography or D-Dimer ...

Eligibility Criteria

Inclusion

  • Patients older than 18 years
  • Patients with non-valvular atrial fibrillation scheduled for direct current cardioversion with prior TEE according to current guidelines
  • Patients willing to sign informed consent

Exclusion

  • Cardiac surgery within the previous 90 days.
  • Coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
  • Significant congenital anomaly or other medical problem that in the opinion of the investigator would preclude enrollment
  • History of blood clotting disease or bleeding abnormalities.
  • Patients with valve implants
  • Women who are pregnant
  • Aortic aneurysm or dissection
  • Documented history of deep vein thrombosis within the last 6 months
  • Documented history of pulmonary embolism within the last 6 months
  • Unwilling or unable to provide informed consent.
  • Recent transient ischemic attack or stroke (90 days)
  • Instable angina

Key Trial Info

Start Date :

January 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 31 2026

Estimated Enrollment :

1368 Patients enrolled

Trial Details

Trial ID

NCT04784039

Start Date

January 1 2025

End Date

January 31 2026

Last Update

February 1 2023

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