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Completed

NCT Number: NCT04223505

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admitted patients who require LA imaging prior to cardioversion
  • Age ≥18 years old
  • Able and willing to comply with the study procedures

Exclusion criteria

  • Indication for acute cardioversion (e.g. hemodynamic instability, acute coronary syndrome (ACS), or pulmonary edema)
  • Unwillingness or inability to provide informed consent
  • Contraindication to Cardiac CT
  • Severe renal insufficiency(GFR< 45ml/min)
  • Allergy to intravenous contrast agents
  • Contraindications to radiation exposure (for example, pregnancy)
  • Inability to perform 20-second breath-hold
  • Contraindication to TEE
  • Unrepaired tracheoesophageal fistula
  • Esophageal obstruction or stricture
  • Perforated hollow viscus
  • Poor airway control
  • Severe respiratory depression
  • Uncooperative, unsedated patient

Treatment and study plan

Contrast enhanced ECG-gated cardiac CT (CCT)

Diagnostic Test

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.

Transesophageal Echocardiography (TEE)

Diagnostic Test

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%.

Primary outcomes

  1. Time to Imaging

    Time frame: From admission to imaging/spontaneous cardioversion, up to approximately 30 days.

    This outcome was measured by calculating the time between admission and imaging.

Secondary outcomes

  1. Time to Cardioversion

    Time frame: From admission to cardioversion, up to approximately 30 days

    This outcome was measured by calculating the time between admission and cardioversion.

Other outcomes

  1. Time to Hospital Discharge

    Time frame: From admission to hospital discharge, up to approximately 90 days.

    This outcome was measured by calculating the time between admission and hospital discharge.

  2. QoL

    Time frame: At hospital discharge

    This outcome was calculated from the following QoLs: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Atrial Fibrillation Impact (AFImpact). EQ-5D-5L health score is a continuous scale from 0 to 100 with 100 being the best outcome. AFImpact scores were calculated using a seven-point Likert Scale (1=none of the time, 7=all of the time). AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) was calculated using all questions in the questionnaire. The difference between AFImpact-VEDS scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 108. AFImpact-emotional distress subscale score was calculated using 8 questions about emotional distress. The difference between AFImpact emotional distress scores at hospital admission and discharge was calculated where minimum change in score is 0 and maximum change in score is 48. The higher change in AFImpact scores represented a better outcome.

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Acronym: LACLOT

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 10, 2020
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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