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

NCT04223505 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-03-12

Study results available
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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

DIAGNOSTIC_TEST

Contrast 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_TEST

Transesophageal 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%.

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Benjamin Chow, MD · UOHI

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-26
Primary Completion
2023-11-21
Completion
2024-01-12

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04223505 on ClinicalTrials.gov