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

NCT04784039 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1368

Last updated 2023-02-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Sébastien Knecht, MD, PhD · AZ Sint-Jan AV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-01-31
Completion
2026-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784039 on ClinicalTrials.gov