Clinical trial NCT04784039: D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation: A Multicenter Belgian Study
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Atrial Fibrillation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 1368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence in thromboembolic events between both groups after 4 weeks follow-up
timeFrame: up to 4 weeks after cardioversion
Secondary outcomes:
measure: Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE
timeFrame: Procedure (At time of cardioversion)
measure: Correlation of DD-value (ng/L) with flow velocity (m/s) in case of spontaneous contrast or suspicion of thrombus in left atrial appendage
timeFrame: Procedure (At time of cardioversion)
Other outcomes:
Locations:
Study officials:
affiliation: AZ Sint-Jan AV
name: Sébastien Knecht, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: