Back to resultsD-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation: A Multicenter Belgian Study (CARDDI-BEL)
Primary Purpose
Atrial Fibrillation
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Transesophageal echocardiography
D-Dimer analysis
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
TEE-group
DD-group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE
Correlation of DD-value (ng/L) with flow velocity (m/s) in case of spontaneous contrast or suspicion of thrombus in left atrial appendage
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04784039
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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2025 (Anticipated)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TEE-group
Arm Type
Active Comparator
Arm Title
DD-group
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Transesophageal echocardiography
Intervention Description
Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE
Intervention Type
Diagnostic Test
Intervention Name(s)
D-Dimer analysis
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence in thromboembolic events between both groups after 4 weeks follow-up
Description
The number of thromboembolic events (stroke, transient ischemic attack, ...) in the TEE and DD-group will be compared
Time Frame
up to 4 weeks after cardioversion
Secondary Outcome Measure Information:
Title
Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE
Time Frame
Procedure (At time of cardioversion)
Title
Correlation of DD-value (ng/L) with flow velocity (m/s) in case of spontaneous contrast or suspicion of thrombus in left atrial appendage
Time Frame
Procedure (At time of cardioversion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Knecht, MD, PhD
Phone
003250452670
Email
sebastien.knecht@azsintjan.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sébastien Knecht, MD, PhD
Organizational Affiliation
AZ Sint-Jan AV
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation: A Multicenter Belgian Study
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