102 Participants Needed

Cardiac Imaging Before Cardioversion for Atrial Fibrillation

(LACLOT Trial)

FA
SJ
Overseen BySandina Jamieson
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is cardiac imaging before cardioversion for atrial fibrillation safe?

Transesophageal echocardiography (TEE) has been used widely and is generally considered safe, with a low complication rate in humans. Cardiac computed tomography angiography (CCTA) is a non-invasive alternative that reduces radiation exposure and is also considered safe.12345

How does the treatment of cardiac imaging before cardioversion for atrial fibrillation differ from other treatments?

This treatment uses advanced imaging techniques like Contrast Enhanced Cardiac CT (CCT) and Transesophageal Echocardiography (TEE) to safely guide cardioversion by screening for blood clots in the heart, potentially allowing for earlier and safer cardioversion compared to traditional methods that rely on prolonged anticoagulation therapy.678910

What data supports the effectiveness of the treatment Cardiac Imaging Before Cardioversion for Atrial Fibrillation?

Research shows that cardiac computed tomography angiography (CCTA) is useful in evaluating heart conditions, such as congenital heart disease, and in guiding treatment after heart procedures. This suggests that CCTA can provide valuable information for managing atrial fibrillation, especially when other imaging methods are unclear.811121314

Who Is on the Research Team?

BC

Benjamin Chow, MD

Principal Investigator

UOHI

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able and willing to comply with the study procedures
I need a heart scan before a procedure to correct my heart rhythm.

Exclusion Criteria

I cannot undergo a Cardiac CT due to health reasons.
I have a hole in an organ like my stomach or intestines.
I have an unrepaired hole between my windpipe and esophagus.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo either contrast-enhanced ECG-gated cardiac CT (CCT) or transesophageal echocardiography (TEE) to rule out LA/LAA thrombus

Up to 30 days
1 visit (in-person)

Cardioversion

Participants undergo cardioversion based on imaging results

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after cardioversion

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Contrast enhanced ECG-gated cardiac CT (CCT)
  • Transesophageal Echocardiography (TEE)
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: CCT armExperimental Treatment2 Interventions
Group II: TEE armActive Control1 Intervention

Contrast enhanced ECG-gated cardiac CT (CCT) is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Contrast Enhanced Cardiac CT for:
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Approved in United States as Contrast Enhanced Cardiac CT for:
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Approved in Canada as Contrast Enhanced Cardiac CT for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Published Research Related to This Trial

In a study of 33 patients with atrial fibrillation, using electrocardiogram (ECG) editing techniques significantly improved the image quality of coronary computed tomography angiography (CCTA), especially when short RR intervals were deleted.
The best image quality was achieved by reconstructing images using the 'R-absolute time method' or 'R+absolute time method', which outperformed traditional methods like Phase Navi, indicating that these ECG-editing techniques are effective for enhancing CCTA in patients with Afib.
[Reconstruction of coronary 64-multidetector-row computed tomography angiography in patients with atrial fibrillation: delete short RR intervals using electorocardiogram].Matsutani, H., Sano, T., Kondo, T., et al.[2019]
In a study of 78 congenital heart disease patients, cardiac computed tomography angiography (CCTA) demonstrated excellent diagnostic performance with a sensitivity of 97.5% and specificity of 100%, making it a highly reliable tool for pre-operative evaluation.
CCTA not only provided critical information for surgical planning but also had a low radiation exposure of 1.41 mSv per study, highlighting its safety and practicality in managing congenital heart disease.
Cardiac computed tomography angiography in the pre-operative assessment of congenital heart disease in Thailand.Chaosuwannakit, N., Makarawate, P., Jantachum, N.[2022]
ECG-gated coronary CT angiography (CCTA) is an effective diagnostic tool for identifying post-procedural complications in heart and thoracic aorta surgeries, with a 9.2% complication rate observed in a study of 294 patients over three years.
The most common complications detected included coronary intimal dissection after percutaneous coronary interventions and right atrial or ventricular perforation after pacemaker implantation, highlighting the importance of CCTA in guiding patient management post-surgery.
ECG-Gated CCTA in the Assessment of Post-Procedural Complications.Liguori, C., Lassandro, G., Ferrandino, G., et al.[2023]

Citations

[Reconstruction of coronary 64-multidetector-row computed tomography angiography in patients with atrial fibrillation: delete short RR intervals using electorocardiogram]. [2019]
Cardiac computed tomography angiography in the pre-operative assessment of congenital heart disease in Thailand. [2022]
ECG-Gated CCTA in the Assessment of Post-Procedural Complications. [2023]
256-Slice coronary computed tomographic angiography in patients with atrial fibrillation: optimal reconstruction phase and image quality. [2020]
Automatic vs manual coronary CT angiography reconstruction for whole-heart coverage CT scanner: a comparison study in general patient population. [2022]
Prospective evaluation of complications associated with transesophageal echocardiography in dogs with congenital heart disease. [2022]
Comparing multislice electrocardiogram-gated spiral computerized tomography and transesophageal echocardiography in evaluating aortic atheroma in patients with acute ischemic stroke. [2019]
Predicting success of prospective and retrospective gating with dual-source coronary computed tomography angiography: development of selection criteria and initial experience. [2019]
Safety of transesophageal echocardiography. A multicenter survey of 10,419 examinations. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
CT assessment of the left atrial appendage post-transcatheter occlusion - A systematic review and meta analysis. [2021]
[Coronary Computed Tomography Angiography for Patients with Atrial Fibrillation: Feasibility of Prospective Electrocardiography-gated Diastolic Acquisition with a Manual Exposure-termination Technique]. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Prevalence and predictors of left atrial thrombus in patients with atrial fibrillation: is transesophageal echocardiography necessary before cardioversion? [2016]
13.United Statespubmed.ncbi.nlm.nih.gov
Cardioversion guided by transesophageal echocardiography: the ACUTE Pilot Study. A randomized, controlled trial. Assessment of Cardioversion Using Transesophageal Echocardiography. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Advanced adaptive axial-sequential prospectively electrocardiogram-triggered dual-source coronary computed tomographic angiography in a patient with atrial fibrillation. [2016]
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