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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Transesophageal echocardiography; Diagnostic test: D-Dimer analysis

• Study Type: Interventional
• Enrollment (Anticipated): 1368
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sébastien Knecht, MD, PhD; Phone Number: 003250452670; Email: sebastien.knecht@azsintjan.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TEE-group	Diagnostic test: Transesophageal echocardiography; Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE
Active Comparator: DD-group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE	Procedure (At time of cardioversion)
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)

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2021
• Last Update Submitted That Met QC Criteria: March 4, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin fragment D
• Other Study ID Numbers: Version 1.0, 25 February 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No