Recruiting

CCT-Facilitated Cardioversion

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT07002450

Conditions

Atrial Fibrillation (AF)

Atrial Flutter

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac computed tomography angiography

Standard of care management

Study Details

Brief summary:

The goal of this randomized clinical trial is to learn whether patients with symptomatic atrial fibrillation or atrial flutter (AF) who require heart imaging to rule out a blood clot before cardioversion would benefit from cardiac computed tomography angiography (CCT) in the emergency department (ED) compared to current standard of care management.

This will be a multicenter trial evaluating whether CCT-facilitated cardioversion in the ED reduces hospital admission, reduces repeat presentations to hospital and improves patient quality of life compared to the current standard of care.

Participants will undergo CCT-facilitated cardioversion or be treated according to current standard of care while in the ED and complete quality of life questionnaires in the ED and follow-up at 30 days.

Conditions

Atrial Fibrillation (AF)

Atrial Flutter

Study ID

NCT07002450

Start date

Jun 15, 2025

Status verified date

Jun, 2026

Completion date

Jun 15, 2028

Anticipated

Primary completion date

Jun 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥18 years old; and
2. Primary symptomatic AF without a reversible underlying cause (e.g. sepsis, pneumonia, pulmonary embolism, hyperthyroidism)
3. LA imaging required before cardioversion according to local clinical practice guidelines

Exclusion Criteria:

1. Patients with an indication for emergency cardioversion (e.g. hemodynamic instability (systolic blood pressure<90mmHg or signs of shock), cardiac ischemia (ongoing severe chest pain or marked ST depression on ECG >2mm), or pulmonary edema (significant dyspnea, crackles, or hypoxia)); or
2. Contraindication to CCT (renal insufficiency (eGFR< 45ml/min/1.73m2), allergy to intravenous contrast agents, pregnancy (contraindications to radiation exposure), or inability to perform 20-second breath-hold)

Study Design

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Standard of Care

Patients in the control arm will be treated according to current standard of care as determined by the primary treating emergency department physician and may vary by institution and physician. Treatment in the standard of care group may include a rate control strategy with or without a planned cardioversion after 3 weeks of anticoagulation, deferring management for outpatient evaluation, request for TEE-facilitated cardioversion in the ED, or specialist consultation for further management or admission to hospital.

experimental: CCT-facilitated cardioversion arm

Patients in this arm will undergo cardiac computed tomography angiography (CCT) to evaluate for a left atrial/left atrial appendage (LA) thrombus. If the CCT shows no LA thrombus then the emergency department physician will be able to perform electrical and/or chemical cardioversion at their discretion. If the CCT shows a LA thrombus then cardioversion will be contraindicated and further management will be at the discretion of the treating physician.

Interventions

Cardiac computed tomography angiography

Patients will undergo CCT according to the following protocol. A non-contrast enhanced prospective ECG-triggered image will be acquired followed by a contrast-enhanced prospective ECG-triggered image using a tri-phasic contrast protocol. Delayed CT images 60 seconds after the initial contrast-enhanced CT scan will be obtained. Cardiac CT image interpretation will be performed according to routine clinical practices in a pragmatic fashion. The LA will be assessed for filling defects and characterized based upon attenuation values. If LA 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. If the CCT shows no LA thrombus then the ED physician will be able to perform electrical and/or chemical cardioversion at their discretion.

Standard of care management

Patients in the standard of care arm may undergo any combination of the following management strategies in the emergency department (ED) at the discretion of their treating physician:

1\. Transesophageal echocardiogram (TEE) facilitated cardioversion; 2. Rate control; 3. Consultation with inpatient cardiac specialist for assessment/management and consideration of hospital admission; 4. cardioversion after 3 weeks of anticoagulation; and/or 5. Outpatient referral to cardiac specialist or general practitioner for further management.

Primary outcome measure

  • Primary composite outcome [ Time Frame: Randomization to 30 days ]

Central Contacts and Locations

Locations

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

The Ottawa Hospital Civic Campus

Recruiting

Ottawa, Ontario, Canada, K1Y 1J8

Contacts

Principal Investigator:

Ian Stiell, MD

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Principal Investigator:

Idan Roifman, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Cardiac computed tomography angiography
  • Cardioversion
  • Atrial flutter
  • Atrial fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-06-09.