Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784039
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-01
First Post:
2021-03-03
Brief Title:
D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation A Multicenter Belgian Study
Sponsor:
AZ Sint-Jan AV
Organization:
AZ Sint-Jan AV
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARDDI-BEL
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 11 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 patients 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
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 11 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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None