Atrial FibrillationPhase 4CARDDI-BELNCT04784039
D-Dimer-based Indication for Transesophageal Echocardiography to Exclude Left Atrial Thrombus Before Cardioversion of Non-anticoagulated Atrial Fibrillation: A Multicenter Belgian Study
A Phase 4 study testing Transesophageal echocardiography and D-Dimer analysis in people with Atrial Fibrillation, run by AZ Sint-Jan AV.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Transesophageal echocardiography and D-Dimer analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,368 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Transesophageal echocardiography, D-Dimer analysis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transesophageal echocardiographyDiagnostic test
Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE
D-Dimer analysisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| TEE-group | Active comparator | Not described Receives: Diagnostic Test: Transesophageal echocardiography |
| DD-group | Active comparator | Not described Receives: Diagnostic Test: D-Dimer analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 4 weeks after cardioversion
Secondary outcomes (2)
Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE
Measured: 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
Measured: Procedure (At time of cardioversion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jan 2025 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Knecht, AZ Sint-Jan AV
- Investigators
- Sébastien Knecht, MD, PhD, Principal investigator, AZ Sint-Jan AV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784039
- Sponsor's protocol ID
- Version 1.0, 25 February 2021
- Acronym
- CARDDI-BEL
- Status last verified
- Jan 2023
- First submitted
- 3 Mar 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04784039
- Acronym / sponsor ID
- CARDDI-BEL / Version 1.0, 25 February 2021
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,368 participants (estimated)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEE-group | Active comparator | Diagnostic Test: Transesophageal echocardiography |
| DD-group | Active comparator | Diagnostic Test: D-Dimer analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transesophageal echocardiographyPatients randomized to the TEE group will be scheduled for cardioversion with prior TEE | Diagnostic test | TEE-group |
| D-Dimer analysisPatients 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 | Diagnostic test | DD-group |
Primary outcome
Incidence in thromboembolic events between both groups after 4 weeks follow-up
Time frame: up to 4 weeks after cardioversion
The number of thromboembolic events (stroke, transient ischemic attack, ...) in the TEE and DD-group will be compared
2 secondary outcomes
Correlation between D-Dimer-value (ng/L) and number of thrombi visible on TEE
Time frame: 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
Time frame: Procedure (At time of cardioversion)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Related trials for Atrial Fibrillation
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
RecruitingObservational study
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
Heart Failure, Atrial Fibrillation (AF)
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruiting
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
Atrial Fibrillation (AF)
Active, not recruiting
ARIADNE Clinical Trial
Persistent Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien Knecht, MD, PhD principal investigator
AZ Sint-Jan AV
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transesophageal echocardiography and D-Dimer analysis in people with Atrial Fibrillation, run by AZ Sint-Jan AV.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Knecht, MD, PhD (003250452670, sebastien.knecht@azsintjan.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence in thromboembolic events between both groups after 4 weeks follow-up (time frame: up to 4 weeks after cardioversion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.