Clinical Trials Directory

Trials / Completed

CompletedNCT04223505

Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
102 (actual)
Sponsor
Ottawa Heart Institute Research Corporation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF and atrial flutter.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTContrast enhanced ECG-gated cardiac CT (CCT)Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude of left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. CCT, compared to TEE, for the exclusion of thrombus in the LAA had a sensitivity and specificity of 100% and 99.3%, respectively. A high sensitivity is needed to minimize risk of embolus, and if a thrombus is detected on CT, a confirmatory TEE may be performed or patients may receive anticoagulation. Some argue that the potential benefits of CT and its lower associated procedural risk, the risk:benefit ratio would still favour CT.
DIAGNOSTIC_TESTTransesophageal Echocardiography (TEE)TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%.

Timeline

Start date
2020-06-26
Primary completion
2023-11-21
Completion
2024-01-12
First posted
2020-01-10
Last updated
2025-03-12
Results posted
2025-03-12

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04223505. Inclusion in this directory is not an endorsement.