Clinical trial NCT07002450: Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)
Official title: Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Atrial Flutter
Keywords: Cardiac computed tomography angiography
Cardioversion
Atrial flutter
Atrial fibrillation
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Primary composite outcome
timeFrame: Randomization to 30 days
Secondary outcomes:
measure: Composite secondary outcome
timeFrame: Randomization to 30 days
measure: Composite objective outcomes
timeFrame: Randomization to 30 days
measure: All-cause death
timeFrame: Randomization to 30 days
measure: Cardiovascular death
timeFrame: Randomization to 30 days
measure: Stroke, transient ischemic attack, or systemic embolism
timeFrame: Randomization to 30 days
measure: Hospital admission for a cardiac reason
timeFrame: Randomization to 30 days
measure: Repeat presentation to the emergency department
timeFrame: Randomization to 30 days
measure: AFEQT quality of life
timeFrame: Randomization to 30 days
measure: SF-36 quality of life
timeFrame: Randomization to 30 days
measure: Bleeding
timeFrame: Randomization to 30 days
measure: Admission to hospital for acute kidney injury
timeFrame: Randomization to 30 days
measure: Length of stay in the emergency department
timeFrame: From time of arrival until time of discharge or admission (approximately 3 hours)
measure: Normal sinus rhythm
timeFrame: At the time of patient disposition (approximately 3 hours after arrival)
Other outcomes:
measure: Cost effectiveness
timeFrame: Emergency department presentation to 30 days
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Civic Campus
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Benjamin Chow, MD PhD FRCPC FACC FESC FA
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Mehrdad Golian, MD MSC FRCPC
role: PRINCIPAL_INVESTIGATOR
References: