NCT04784039

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,368 (estimated)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transesophageal echocardiography	Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE
DIAGNOSTIC_TEST	D-Dimer analysis	Patients randomized to the DD-group will be scheduled for cardioversion with prior D-Dimer analysis. In case of positive D-Dimer results, TEE will be performed prior to cardioversion

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2021-03-05
• Last updated: 2023-02-01