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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights

LACLOT Trial 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.Check my eligibility
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.See study design
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.

LACLOT Trial 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.

LACLOT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to cardioversion
Secondary outcome measures
Hospital admission rate
Other outcome measures
Adverse events
Length of hospital stay

LACLOT 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

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,474 Total Patients Enrolled
23 Trials studying Atrial Fibrillation
6,591 Patients Enrolled for Atrial Fibrillation
Benjamin Chow, MDPrincipal InvestigatorUOHI
3 Previous Clinical Trials
248 Total Patients Enrolled

Media Library

Contrast enhanced ECG-gated cardiac CT (CCT) Clinical Trial Eligibility Overview. Trial Name: NCT04223505 — N/A
Atrial Fibrillation Clinical Trial 2023: Contrast enhanced ECG-gated cardiac CT (CCT) Highlights & Side Effects. Trial Name: NCT04223505 — N/A
Atrial Fibrillation Research Study Groups: CCT arm, TEE arm
Contrast enhanced ECG-gated cardiac CT (CCT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04223505 — N/A

Frequently Asked Questions

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~4 spots leftby Jun 2024