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

Atrial Fibrillation Clinical Trial

— CARDDI-BEL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04784039
• Other study ID #: Version 1.0, 25 February 2021
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 1, 2025
• Est. completion date: January 31, 2026

Study information

• Verified date: January 2023
• Source: AZ Sint-Jan AV
• Contact: Sébastien Knecht, MD, PhD
• Phone: 003250452670
• Email: sebastien.knecht[@]azsintjan.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1368
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Transesophageal echocardiography
Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence in thromboembolic events between both groups after 4 weeks follow-up	The number of thromboembolic events (stroke, transient ischemic attack, ...) in the TEE and DD-group will be compared	up to 4 weeks after cardioversion
Secondary	Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE		Procedure (At time of cardioversion)
Secondary	Correlation of DD-value (ng/L) with flow velocity (m/s) in case of spontaneous contrast or suspicion of thrombus in left atrial appendage		Procedure (At time of cardioversion)