NCT04223505: LACLOT

Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus

Completed NA Results posted Last updated 12 March 2025

What this trial tests

NA trial testing Contrast enhanced ECG-gated cardiac CT (CCT) in Atrial Fibrillation in 102 participants. Completed in 12 January 2024.

Timeline

26 June 2020

Primary endpoint
21 November 2023

12 January 2024

Quick facts

Lead sponsor	Ottawa Heart Institute Research Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	102
Start date	26 June 2020
Primary completion	21 November 2023
Estimated completion	12 January 2024
Sites	1 location across Canada

Drugs / interventions tested

• Contrast enhanced ECG-gated cardiac CT (CCT)
• Transesophageal Echocardiography (TEE)

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →

Sponsor

Ottawa Heart Institute Research Corporation

Who can join

18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Imaging Primary · From admission to imaging/spontaneous cardioversion, up to approximately 30 days.

This outcome was measured by calculating the time between admission and imaging.

Group	Value	95% CI
TEE Arm	28.1	± 34.9
CCT Arm	7.1	± 12.5

Time to Cardioversion Secondary · From admission to cardioversion, up to approximately 30 days

This outcome was measured by calculating the time between admission and cardioversion.

Group	Value	95% CI
TEE Arm	4.6	± 11.1
CCT Arm	1.7	± 1.8

Time to Hospital Discharge Secondary · From admission to hospital discharge, up to approximately 90 days.

This outcome was measured by calculating the time between admission and hospital discharge.

Group	Value	95% CI
TEE Arm	6.7	± 6.9
CCT Arm	7.0	± 10.8

QoL Secondary · At hospital discharge

This outcome was calculated from the following QoLs: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) and Atrial Fibrillation Impact (AFImpact). EQ-5D-5L health score is a continuous scale from 0 to 100 with 100 being the best outcome. AFImpact scores were calculated using a seven-point Likert Scale (1=none of the time, 7=all of the time). AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS) was calculated using all questions in the questionnaire. The difference between AFImpact-VEDS scores at hospital admission and discharge was calculated where minimum change in

European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)

Group	Value	95% CI
TEE Arm	68.1	± 18.2
CCT Arm	75.3	± 15.5

AFImpact-Vitality, Emotional Distress, Sleep score (AFImpact-VEDS)

Group	Value	95% CI
TEE Arm	8.5	± 4.2
CCT Arm	7.5	± 3.5

Atrial Fibrillation Impact (AFImpact)-emotional distress

Group	Value	95% CI
TEE Arm	3.0	± 1.8
CCT Arm	2.4	± 1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for 1 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TEE Arm

Serious: 0/50 (0%)

Deaths: 1/50

CCT Arm

Serious: 0/52 (0%)

Deaths: 1/52

Other adverse events (1 terms — click to expand)

Reaction	System	TEE Arm	CCT Arm
Renal impairment	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT04223505 adverse events section.

Sponsor's own description

Evaluating contrast enhanced ECG-gated cardiac CT (CCT) as an alternative to transesophageal echocardiography (TEE) to expedite cardioversion of atrial fibrillation (AF), improve patient care and reduce hospital admissions for AF and atrial flutter.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.