D-Dimer-based Indication for Transesophageal Echocardiogr... | NCT04784039

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2025Estimated

Primary Completion Date

Jan 31, 2026Estimated

Completion Date

Jan 31, 2026Estimated

First Submitted Date

Mar 3, 2021

First Submission Date that Met QC Criteria

Mar 4, 2021

First Posted Date

Mar 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2023

Last Update Posted Date

Feb 1, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,368Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEE-group	Active Comparator		Diagnostic Test: Transesophageal echocardiography
DD-group	Active Comparator		Diagnostic Test: D-Dimer analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transesophageal echocardiography	Diagnostic Test	Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE	TEE-group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sébastien Knecht, MD, PhD	Contact	003250452670		sebastien.knecht@azsintjan.be

Overall Officials

Name	Affiliation	Role
Sébastien Knecht, MD, PhD	AZ Sint-Jan AV	Principal Investigator

Locations

Not provided

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D004452	Echocardiography
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D014463	Ultrasonography
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular