Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)

Part of paid clinical trials in Hershey, Pennsylvania.

Sponsor
Ottawa Heart Institute Research Corporation
Study ID
NCT07002450
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)
  • Atrial Flutter

Eligibility Criteria

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

Interventions

  • Cardiac computed tomography angiography — DIAGNOSTIC_TEST
    Patients will undergo CCT according to the following protocol. A non-contrast enhanced prospective ECG-triggered image will be acquired followed by a contrast-enhanced prospective ECG-triggered image using a tri-phasic contrast protocol. Delayed CT images 60 seconds after the initial contrast-enhanced CT scan will be obtained. Cardiac CT image interpretation will be performed according to routine clinical practices in a pragmatic fashion. The LA will be assessed for filling defects and characterized based upon attenuation values. If LA thrombus cannot be excluded, filling defects will be assessed on the delay images. Increases in attenuation would be consistent with pseudo-thrombus from 'slow flow' and 'incomplete opacification'. Areas where attenuation does not change significantly (persistent filling defect) will be diagnosed as thrombus. If the CCT shows no LA thrombus then the ED physician will be able to perform electrical and/or chemical cardioversion at their discretion.
  • Standard of care management — OTHER
    Patients in the standard of care arm may undergo any combination of the following management strategies in the emergency department (ED) at the discretion of their treating physician: 1\. Transesophageal echocardiogram (TEE) facilitated cardioversion; 2. Rate control; 3. Consultation with inpatient cardiac specialist for assessment/management and consideration of hospital admission; 4. cardioversion after 3 weeks of anticoagulation; and/or 5. Outpatient referral to cardiac specialist or general practitioner for further management.

Study Details

The goal of this randomized clinical trial is to learn whether patients with symptomatic atrial fibrillation or atrial flutter (AF) who require heart imaging to rule out a blood clot before cardioversion would benefit from cardiac computed tomography angiography (CCT) in the emergency department (ED) compared to current standard of care management. This will be a multicenter trial evaluating whether CCT-facilitated cardioversion in the ED reduces hospital admission, reduces repeat presentations to hospital and improves patient quality of life compared to the current standard of care. Participants will undergo CCT-facilitated cardioversion or be treated according to current standard of care while in the ED and complete quality of life questionnaires in the ED and follow-up at 30 days.

Key Dates

Start date
Jun 15, 2025
Status verified
Jun 2026
Primary completion
Jun 15, 2028
Completion
Jun 15, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Standard of Care
    Patients in the control arm will be treated according to current standard of care as determined by the primary treating emergency department physician and may vary by institution and physician. Treatment in the standard of care group may include a rate control strategy with or without a planned cardioversion after 3 weeks of anticoagulation, deferring management for outpatient evaluation, request for TEE-facilitated cardioversion in the ED, or specialist consultation for further management or admission to hospital.
  • Experimental: CCT-facilitated cardioversion arm
    Patients in this arm will undergo cardiac computed tomography angiography (CCT) to evaluate for a left atrial/left atrial appendage (LA) thrombus. If the CCT shows no LA thrombus then the emergency department physician will be able to perform electrical and/or chemical cardioversion at their discretion. If the CCT shows a LA thrombus then cardioversion will be contraindicated and further management will be at the discretion of the treating physician.

Primary Outcome Measure

Primary composite outcome [ Time Frame: Randomization to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Penn State Health Milton S. Hershey Medical CenterHersheyPennsylvania17033
Murtaza Akhter, MD
[email protected]
603-418-2868

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By research site
Penn State Health Milton S. Hershey Medical Center· Hershey, PA

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