Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this randomized, controlled trial is to investigate whether coronary computed tomography (CT) angiography and derived treatment (medical anti-ischemic and multimodality treatment and/or mechanical revascularization) prior to catheter ablation improve clinical outcomes in patients with atrial fibrillation.

Detailed Description
-----------------
The study is an investigator-initiated, prospective, randomized, unblinded, controlled trial to investigate whether coronary CT angiography and derived treatment prior to catheter ablation improve clinical outcomes in patients with atrial fibrillation. The study population will consist of approximately 852 patients aged 18 years and above referred for a catheter ablation treatment for atrial fibrillation at Gentofte Hospital in Denmark. All participants included in the study will have a coronary CT angiography and coronary artery calcium (CAC) scoring performed as an amendment to the standard CT scan of the heart for mapping of the atria prior to catheter ablation. The participants are randomized 1:1 to either have the coronary CT angiography analyzed or not prior to the catheter ablation. According to the results of the coronary CT angiography in the intervention group, subsequent actions may include intensified multimodality medical treatment or referral to invasive coronary angiography and possibly mechanical revascularization according to clinical guidelines. The study will be completed when each patient has been followed for at least 1 year. The primary endpoint is time to first documented recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up.

Official Title
-----------------
Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Diagnostic Test: Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age over 18 years Referral for catheter ablation treatment (excluding AV-junction ablation) for atrial fibrillation (all types of atrial fibrillation are included - paroxysmal, persistent, long-term persistent and permanent) at the Department of Cardiology at Gentofte Hospital. Both first ablation and re-ablation treatments are included. The ability and willingness to provide written informed consent Exclusion Criteria: Known atherosclerotic cardiovascular disease (ASCVD) Ongoing treatment with statins Contraindications for coronary CT angiography, e.g. contrast allergy Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Analysis of coronary CT angiography and CAC scoring prior to catheter ablation<br>Based on the results of the coronary CT angiography and CAC scoring in the intervention group, relevant anti-ischemic and multimodality treatment will be initiated according to clinical guidelines. | Diagnostic Test: Analysis of coronary CT Angiography and CAC scoring prior to catheter ablation<br>* Analysis of coronary CT angiography and CAC scoring and derived treatment prior to catheter ablation.<br>|
| No Intervention: No analysis of coronary CT angiography and CAC scoring prior to catheter ablation<br>Patients in the control group will follow the current standard of care prior to ablation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference in time to first recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up. |  | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Between-group difference in time to first documented occurrence of other arrhythmias after ablation |  | Up to 4 years | 
| Between-group difference in the number of participants hospitalized for angina pectoris and acute coronary syndrome after ablation |  | Up to 4 years | 
| Between-group difference in the incidence of acute myocardial infarction after ablation |  | Up to 4 years | 
| Between-group difference in the number of patients undergoing revascularization procedures after ablation |  | Up to 4 years | 
| Between-group difference in the number of deaths due to cardiovascular disease after ablation |  | Up to 4 years | 
| Between-group difference in incidence of stroke after ablation |  | Up to 4 years | 
| Between-group difference in incidence of heart failure or heart failure hospitalization after ablation |  | Up to 4 years | 
| Between-group difference in number of participants hospitalized for atrial fibrillation after ablation |  | Up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statins, Coronary Artery Disease, Coronary Computed Tomography Angiography, Atrial Fibrillation, Ischemic heart disease, Catheter Ablation, Atherosclerosis, Cardiovascular Diseases, Randomized Controlled Trial