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

Not Applicable

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04223505
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2020-06-26
• Primary Completion: 2023-11-21
• Study Completion: 2024-01-12
• Results First Submitted: 2024-04-16
• Status Verified: 2024-09
• Results First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Results First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Imaging	From admission to imaging/spontaneous cardioversion, up to approximately 30 days.	This outcome was measured by calculating the time between admission and imaging.

Secondary Outcome Measures

Name	Time	Method
Time to Cardioversion	From admission to cardioversion, up to approximately 30 days	This outcome was measured by calculating the time between admission and cardioversion.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada