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

AZ Sint-Jan AV

Status and phase

Not yet enrolling

Phase 4

Conditions

Atrial Fibrillation

Treatments

Diagnostic Test: Transesophageal echocardiography

Diagnostic Test: D-Dimer analysis

Study type

Interventional

Funder types

Other

Identifiers

NCT04784039

Version 1.0, 25 February 2021

Details and patient eligibility

About

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 (DD) analysis.

Patients in need of a direct current cardioversion (DCCV), meeting the criteria for DCCV with prior transesophageal echocardiography (TEE), will be asked to participate in the CARDDI-BEL study.

Patients will be randomized on a 1:1 ratio to the TEE-group or DD-group. Patients in the TEE-group will receive TEE prior to cardioversion to exclude left atrial thrombus according to current guidelines [1]. In patients randomized to the DD-group, D-Dimer will be analyzed (cut-off defined by DDage). If the DDage > 10x patient's age, the analysis is suggestive for the presence of left atrial thrombus and the cardioversion will be performed with prior TEE. In case of negative DDage, no TEE will be used in the DD-group.

Enrollment

1,368 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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