Language: BG BG
← Back to results
Recruiting Not applicable NCT07002450

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

No applicable phase (e.g. observational)
Conditions: Atrial Fibrillation (AF) Atrial Flutter

Sponsor: Ottawa Heart Institute Research Corporation

trial.available_in: БГ
Overview
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.
Description
Atrial fibrillation and atrial flutter (AF) are the most common cardiac arrhythmias worldwide resulting in frequent visits to the emergency department (ED). Some patients can undergo chemical or electrical cardioversion to restore their heart back to a sinus rhythm. However, if a patient is not on blood thinners and the duration of AF is prolonged then blood clots may form in the heart increasing the risk of stroke after cardioversion. Therefore, some patients must undergo heart imaging to rule out any blood clots before cardioversion is considered safe. Transesophageal echocardiography (TEE) is commonly used to rule out blood clots, but it is not readily available in all EDs often resulting in hospital admission to facilitate this test or deferring cardioversion until 3 weeks of blood thinners have been completed. Cardiac computed tomography angiography (CCT) is a more readily available alternative to TEE that can be done rapidly in the ED. CCT has excellent sensitivity and specificity compared to TEE for identifying cardiac thrombus. If there is no thrombus detected on the CCT then patients could be immediately cardioverted to sinus rhythm thus avoiding an unnecessary hospital admission and reducing the symptom burden associated with remaining in AF. This study is a multicenter randomized trial that will evaluate the effectiveness of using CCT facilitated cardioversion in the ED compared to current standard of care management.
Who can participate
Inclusion Criteria: 1. Age ≥18 years old; and 2. Primary symptomatic AF without a reversible underlying cause (e.g. sepsis, pneumonia, pulmonary embolism, hyperthyroidism) 3. LA imaging required before cardioversion according to local clinical practice guidelines Exclusion Criteria: 1. 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 2. 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)
Interventions
Cardiac computed tomography angiography
DIAGNOSTIC_TEST
Standard of care management
OTHER
Locations 1
Canada (1)
The Ottawa Hospital Civic Campus
Ottawa , Ontario
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.06.2025
Completion date
15.06.2028
Registry ID
NCT07002450
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.