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

NCT ID: NCT04784039

Last Updated: 2023-02-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 1368 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-01-31

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 (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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TEE-group

Group Type: ACTIVE_COMPARATOR

Transesophageal echocardiography

Intervention Type: DIAGNOSTIC_TEST

Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE

DD-group

Group Type: ACTIVE_COMPARATOR

D-Dimer analysis

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Transesophageal echocardiography

Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Sebastien Knecht

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sébastien Knecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Jan AV

Central Contacts

Sébastien Knecht, MD, PhD

Role: CONTACT

sebastien.knecht@azsintjan.be

003250452670

Other Identifiers

Version 1.0, 25 February 2021

Identifier Type: -

Identifier Source: org_study_id