Atrial Fibrillation Clinical Trials

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Left Atrial Imaging Prior to Cardioversion: Leveraging Computed Tomography to Rule Out Thrombus in The Emergency Department (LA CLOTTED)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old; and

• Primary symptomatic AF without a reversible underlying cause (e.g. sepsis, pneumonia, pulmonary embolism, hyperthyroidism)

• LA imaging required before cardioversion according to local clinical practice guidelines

Locations
United States
Pennsylvania
Penn State Health Milton S. Hershey Medical Center
RECRUITING
Hershey
Other Locations
Canada
The Ottawa Hospital Civic Campus
RECRUITING
Ottawa
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Farrah Ahmed
fahmed@ottawaheart.ca
613-696-7000
Backup
Yeung Yam
yyam@ottawaheart.ca
613-696-7000
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2028-06-15
Participants
Target number of participants: 190
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Heart Institute Research Corporation

This content was sourced from clinicaltrials.gov