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

Atrial Fibrillation Clinical Trial

— LACLOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223505
• Other study ID #: 201900117-01H
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: August 30, 2025

Study information

• Verified date: July 2023
• Source: Ottawa Heart Institute Research Corporation
• Contact: Farrah Ahmed
• Phone: 613-696-7000
• Email: fahmed[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Admitted patients who require LA imaging prior to cardioversion

2. Age =18 years old

3. Able and willing to comply with the study procedures

Exclusion Criteria:

1. Indication for acute cardioversion (e.g. hemodynamic instability, acute coronary syndrome (ACS), or pulmonary edema)

2. Unwillingness or inability to provide informed consent

3. Contraindication to Cardiac CT

• Severe renal insufficiency(GFR< 45ml/min)

• Allergy to intravenous contrast agents

• Contraindications to radiation exposure (for example, pregnancy)

• Inability to perform 20-second breath-hold

4. Contraindication to TEE

• Unrepaired tracheoesophageal fistula

• Esophageal obstruction or stricture

• Perforated hollow viscus

• Poor airway control

• Severe respiratory depression

• Uncooperative, unsedated patient

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Contrast enhanced ECG-gated cardiac CT (CCT)
Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude of left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. CCT, compared to TEE, for the exclusion of thrombus in the LAA had a sensitivity and specificity of 100% and 99.3%, respectively. A high sensitivity is needed to minimize risk of embolus, and if a thrombus is detected on CT, a confirmatory TEE may be performed or patients may receive anticoagulation. Some argue that the potential benefits of CT and its lower associated procedural risk, the risk:benefit ratio would still favour CT.
• Transesophageal Echocardiography (TEE)
TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%.

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of hospital stay		Up to 30 days
Other	Adverse events		Up to 30 days
Primary	Time to cardioversion		Up to 30 days
Secondary	Hospital admission rate		Up to 30 days