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

Recruiting · NCT07002450 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Heart Institute Research Corporation

View the official record on ClinicalTrials.gov →

Atrial fibrillation

Interventions studied

Cardiac computed tomography angiographyStandard of care management

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

Age ≥18 years old; and
Primary symptomatic AF without a reversible underlying cause (e.g. sepsis, pneumonia, pulmonary embolism, hyperthyroidism)
LA imaging required before cardioversion according to local clinical practice guidelines

Exclusion criteria

Patients with an indication for emergency cardioversion (e.g. hemodynamic instability (systolic blood pressure\<90mmHg or signs of shock), cardiac ischemia (ongoing severe chest pain or marked ST depression on ECG \>2mm), or pulmonary edema (significant dyspnea, crackles, or hypoxia)); or
Contraindication to CCT (renal insufficiency (eGFR\< 45ml/min/1.73m2), allergy to intravenous contrast agents, pregnancy (contraindications to radiation exposure), or inability to perform 20-second breath-hold)

Where it is running

3 locations listed across 1 US state.

Penn State Health Milton S. Hershey Medical Center - Hershey, Pennsylvania, United States
The Ottawa Hospital Civic Campus - Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre - Toronto, Ontario, Canada

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →