Cardiac CT Angiography for Atrial Fibrillation and Flutter

(LA CLOTTED Trial)

Overseen By Farrah Ahmed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Heart Institute Research Corporation

Disqualifiers: Hemodynamic instability, Cardiac ischemia, Pulmonary edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Approximately 3 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to manage atrial fibrillation or atrial flutter (irregular heartbeats) in the emergency department using cardiac computed tomography angiography (CCT). The goal is to determine if this scan can help doctors make faster decisions, avoid hospital admissions, and improve quality of life compared to current methods. Participants will either receive the CCT scan or follow the usual treatment approach to compare outcomes. The trial seeks individuals with ongoing symptoms of atrial fibrillation who need a heart scan before undergoing a procedure to restore normal heart rhythm. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform emergency heart care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that cardiac computed tomography angiography is safe for patients with atrial fibrillation or flutter?

Previous studies have shown that cardiac computed tomography angiography (CCT) is a safe and well-tolerated procedure. Research indicates that CCT, a non-invasive method, carries fewer risks than some other imaging techniques. For instance, CCT effectively detects heart problems, making it a reliable choice for patients. It can identify issues without causing harm.

While every medical procedure carries some risk, evidence shows that serious problems with CCT are rare and usually minor. This makes it a promising option for heart imaging, particularly for detecting blood clots before treatments like cardioversion, which helps restore a regular heart rhythm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using cardiac computed tomography angiography (CCT) for atrial fibrillation and flutter because it offers a unique way to assess the presence of left atrial thrombus quickly and non-invasively. Unlike the standard of care, which might involve weeks of anticoagulation before cardioversion or complex decision-making involving transesophageal echocardiograms, CCT provides rapid imaging results that can immediately inform treatment decisions. This fast evaluation can allow for quicker cardioversion if no thrombus is present, potentially reducing the time patients spend in irregular heart rhythms and enhancing their overall care experience.

What evidence suggests that cardiac computed tomography angiography is effective for atrial fibrillation and flutter?

Research has shown that cardiac computed tomography angiography (CCT), which participants in this trial may receive, is a promising tool for detecting blood clots in the heart. One study found that CCT effectively detects clots in the left atrial appendage, a common location for clots in individuals with atrial fibrillation or flutter. This imaging method can effectively rule out clots, allowing doctors to safely perform cardioversion, a procedure to reset the heart's rhythm. By using CCT, doctors may lower the risk of strokes and improve patient outcomes compared to traditional methods. Overall, CCT offers a non-invasive way to assess heart health and guide treatment decisions. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin Chow, MD PhD FRCPC FACC FESC FA

Principal Investigator

Ottawa Heart Institute Research Corporation

Mehrdad Golian, MD MSC FRCPC

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for patients with symptomatic atrial fibrillation or flutter needing to check for blood clots before cardioversion. It's not specified who can't join, but typically those with certain health risks or conditions that conflict with the study requirements would be excluded.

Inclusion Criteria

I've had heart imaging before a procedure to correct heart rhythm, as per guidelines.

I am 18 years old or older.

I have atrial fibrillation not caused by another treatable condition.

Exclusion Criteria

I need an urgent procedure to correct my heart rhythm due to severe symptoms.

I cannot have CCT due to kidney issues, allergies to contrast agents, pregnancy, or difficulty holding my breath.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo CCT-facilitated cardioversion or standard care management in the emergency department

Approximately 3 hours

1 visit (in-person)

Follow-up

Participants complete quality of life questionnaires and are monitored for safety and effectiveness

30 days

1 visit (in-person), 1 follow-up (virtual or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac computed tomography angiography

Trial Overview The study compares two approaches: using cardiac computed tomography angiography (CCT) in the emergency department versus standard care to prepare for heart rhythm normalization (cardioversion). The aim is to see if CCT leads to fewer hospital stays and better quality of life.

How Is the Trial Designed?

Group I: CCT-facilitated cardioversion arm Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/circ.152.suppl_3.4364910

Abstract 4364910: Trends and Stroke Outcomes in Left ... However, cardiac computed tomography angiography (CCTA) has emerged as a non-invasive, lower-risk alternative with high sensitivity and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4743466/

CT coronary angiography in atrial fibrillation Diagnostic performance of 320-detector CT coronary angiography in patients with atrial fibrillation: preliminary results. Eur Radiol 2011; 21: 936–43. doi ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0002914922004234

Five-Year Outcomes After Coronary Computed ... Five-year all-cause mortality were 2.8% versus 4.2%, 5.5% versus 8.8%, and 6.7% versus 8.5%, all p <0.001. In conclusion, the 5-year MI or ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/s1547-5271(15)01131-5/fulltext

Effectiveness of integrating delayed computed tomography ... Computed tomography angiography (CTA) can identify and rule out left atrial appendage (LAA) thrombus when delayed imaging is also performed.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07002450

NCT07002450 | Left Atrial Imaging Prior to Cardioversion: ... This study is a multicenter randomized trial that will evaluate the effectiveness of using CCT facilitated cardioversion in the ED compared to current standard ...

6. aetna.com aetna.com/cpb/medical/data/200_299/0228.html

Cardiac Computed Tomography (CT), Coronary CT ... This Clinical Policy Bulletin addresses cardiac computed tomography (CT), coronary CT angiography, calcium scoring and CT fractional flow reserve.

7. journalofcardiovascularct.com journalofcardiovascularct.com/article/S1934-5925(20)30473-1/fulltext

SCCT 2021 Expert Consensus Document on Coronary ... The identification of both obstructive and non-obstructive CAD is associated with worse prognosis in patients undergoing CTA. The COronary CT ...