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Cardiac Imaging Before Cardioversion for Atrial Fibrillation (LACLOT Trial)

N/A

Recruiting

Led By Benjamin Chow, MD

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted patients who require LA imaging prior to cardioversion

Age ≥18 years old

Must not have

Contraindication to Cardiac CT

Perforated hollow viscus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether using CT to guide cardioversion of AF is as effective as using TEE.

Who is the study for?

This trial is for adults over 18 who need imaging of the left atrium before cardioversion, a procedure to correct heart rhythm. Participants must be able to hold their breath for 20 seconds and follow study procedures. It's not for pregnant individuals, those with severe kidney issues (GFR<45ml/min), or certain medical conditions like esophageal problems, unstable heart conditions, or allergies to contrast agents.

What is being tested?

The study is testing if a type of CT scan can replace an echocardiogram for checking the left atrium in patients with atrial fibrillation before they undergo cardioversion. The goal is to see if this can speed up treatment and reduce hospital stays.

What are the potential side effects?

Possible side effects include reactions to the contrast agent used in both CCT and TEE such as allergic reactions or kidney function impairment. There may also be risks associated with radiation exposure from the CT scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a heart scan before a procedure to correct my heart rhythm.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot undergo a Cardiac CT due to health reasons.

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I have a hole in an organ like my stomach or intestines.

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I have an unrepaired hole between my windpipe and esophagus.

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I have a blockage or narrowing in my esophagus.

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I have severe difficulty breathing.

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I need an urgent procedure to correct my heart rhythm due to severe symptoms.

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I cannot hold my breath for 20 seconds.

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CCT armExperimental Treatment2 Interventions

As per local protocol, a non-contrast enhanced prospective ECG-triggered image acquisition will be acquired. This will be followed by a contrast-enhanced prospective ECG-triggered will be acquired using a tri-phasic contrast protocols. Delayed CT images will be acquired 60 seconds after the initial contrast-enhanced CT scan.Cardiac CT image interpretation will be performed as per clinical routine. The LA and LAA will be assess for filling defects and characterized based upon attenuation values. If LA/LAA 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. It will be recommended that patients with thrombus will undergo TEE.

Group II: TEE armActive Control1 Intervention

TEE will be performed as per clinical routine using multiple standard tomographic planes to rule-out LA/LAA thrombus. Echocardiographic analysis will include: LAA-emptying velocity, and grading the severity of LAA spontaneous ECHO. The severity of the SEC will be graded on a 4 point scale with 1 = minor homogeneous contrast enhancement, 2 = significant homogeneous contrast enhancement, 3 = significant, dense, and inhomogeneous, slow-moving contrast, and 4 = dense slow-moving contrast.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transesophageal Echocardiography (TEE)

2013

N/A

~40

0 / 10Eligibility criteria met