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

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT07647939
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Left Atrial Appendage Thrombosis
  • Pulmonary Embolism (PE)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Delayed Un-gated CT Scan Arm
    This arm will include the first 30 patients, who will undergo a 60-second delayed, un-gated CT scan to assess the left atrial appendage.
  • Experimental: Delayed Gated CT Scan Arm
    This arm will include the subsequent 30 patients, who will undergo a 60-second delayed, gated CT scan to assess the left atrial appendage.

Primary Outcome Measure

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
North Shore University HospitalManhassetNew York11030
Tabetha Garver-Mosher
516-562-0100
Ana Centeno Rahbani
Ramanak Mitra, MD (PRINCIPAL_INVESTIGATOR)

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