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NCT Number: NCT07647939

Exclusion of Left Atrial Appendage Thrombus in Emergency Department Patients With Atrial Fibrillation Undergoing CT to Assess for Pulmonary Embolus: A Feasibility Study

This study aims to investigate whether a quick, additional CT scan of the heart, performed immediately after a standard CT scan for pulmonary embolism, can effectively detect blood clots in the left atrial appendage (LAA) in patients with atrial fibrillation. Detecting these clots is crucial before certain heart procedures to prevent stroke. Currently, a different, more involved procedure (Transesophageal Echocardiography - TEE) is often used. This study will assess if this additional CT scan is feasible, meaning if it can provide clear enough images to identify LAA clots without needing more contrast dye. The study will involve 60 patients, half receiving an "ungated" CT scan and the other half a "gated" CT scan (timed with their heart rhythm). The results of these scans will not be used for immediate patient care during the study, but rather to evaluate the CT scan technique itself. There is no direct benefit to participants, but the information gained could lead to faster diagnosis and reduced unnecessary testing for future patients.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Embolism Embolism and Thrombosis Heart Diseases Left Atrial Appendage Thrombosis Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Pulmonary Embolism (PE) Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location contact

Ana Centeno Rahbani

CONTACT

[email protected]

Ramanak Mitra, MD

PRINCIPAL_INVESTIGATOR

Tabetha Garver-Mosher

CONTACT

[email protected]

516-562-0100 ext. 1514

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients above 18 years of age years deemed candidates for CT angiography for pulmonary embolism by the primary team on clinical grounds and noted to be in atrial fibrillation at the time.
  • Room air oxygen saturation above 92%
  • Systolic blood pressure above 100 mm Hg
  • Respiratory rate less than 24 breaths/min

Exclusion criteria

  • Inability to personally give informed consent
  • Pregnant or breastfeeding individuals
  • Stroke like symptoms
  • ECG criteria for ischemia or infarction
  • Heart rate <40 or > 120 bpm (inclusive) or 3rd degree heart block
  • Unable to lie flat for at least 10 minutes
  • Unable to follow simple commands
  • Northwell Health Employees.
  • Non-English-speaking patients

Treatment and study plan

Delayed Un-gated CT Scan for Left Atrial Appendage Thrombus

Device

Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed un-gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given.

Delayed Gated CT Scan for Left Atrial Appendage Thrombus

Device

Patients already undergoing CT angiography for suspected pulmonary embolism will receive an additional, delayed gated CT scan (60 seconds after initial contrast injection) to assess for LAA clot. No additional intravenous contrast will be given.

Primary outcomes

  1. Percentage of Indeterminate Left Atrial Appendage (LAA) Thrombus Scans

    Time frame: The overall assessment and statistical analysis of this primary outcome for feasibility determination will be conducted at the study completion, an average of one year.

    The primary endpoint of this study is to test the hypothesis that less than or equal to 20% of the repeat CT scan (described above) will be indeterminate for the presence or absence of left atrial appendage thrombus. Additionally, the proportion of indeterminate gated CT scans will be compared to the proportion of indeterminate ungated CT scans.

Secondary outcomes

  1. Diagnostic Accuracy of Repeat CT Scan for Left Atrial Appendage (LAA) Thrombus Detection.

    Time frame: The secondary outcome will only be calculated at the end of the study (expected date of one year from the first enrollment) if statistically appropriate.

    The secondary outcome of this study will be calculation of the negative and positive predictive value of this additional CT scan for detection of left atrial appendage thrombus, in the study population.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Canon Medical Systems, USA

Registry information

Acronym: ELATE-AF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

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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