NCT04784039

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,368

participants targeted

Target at P75+ for phase_4 atrial-fibrillation

Timeline
Completed

Started Jan 2025

Shorter than P25 for phase_4 atrial-fibrillation

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
3.8 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

March 3, 2021

Last Update Submit

January 31, 2023

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

Study Arms (2)

TEE-group

ACTIVE COMPARATOR
Diagnostic Test: Transesophageal echocardiography

DD-group

ACTIVE COMPARATOR
Diagnostic Test: D-Dimer analysis

Interventions

Transesophageal echocardiographyDIAGNOSTIC_TEST

Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE

TEE-group
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

DD-group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EchocardiographyCardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Sébastien Knecht, MD, PhD

    AZ Sint-Jan AV

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien Knecht, MD, PhD

CONTACT

003250452670sebastien.knecht@azsintjan.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2021

First Posted

March 5, 2021

Study Start

January 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

February 1, 2023

Record last verified: 2023-01