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The purpose of this randomized, controlled trial is to investigate whether coronary computed tomography (CT) angiography prior to catheter ablation and derived treatment (medical anti-ischemic and multimodality treatment and/or mechanical revascularization) can improve clinical outcomes in patients with atrial fibrillation undergoing catheter ablation.
A sub-study will investigate the effect of different ablation strategies on clinical outcomes in patients with atrial fibrillation undergoing catheter ablation.
The study is an investigator-initiated, prospective, randomized, unblinded, controlled trial to investigate whether coronary CT angiography prior to catheter ablation and derived treatment can improve clinical outcomes in patients with atrial fibrillation undergoing catheter ablation. 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 at the time of 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 further functional imaging or 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. After ablation, an insertable cardiac monitor will be implanted in participants to monitor the heart rhythm continuously throughout the study period.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.
All participants meeting the eligibility criteria and enrolled in the FIBCAG main study are eligible to participate in a sub-study with the purpose of investigating different catheter ablation strategies by sub-randomizing participants to different ablation protocols depending on whether they have paroxysmal or persistent atrial fibrillation or they are undergoing first or redo ablation:
All ablation procedures and strategies are currently standard interventions in clinical care. Procedures are performed under general anesthesia or deep sedation based on availability, and patients are blinded to the method of ablation. PVI will be performed according to best current clinical practice using pulsed field ablation with a single shot device or by point-by-point ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Analysis of coronary CT angiography and CAC scoring at the time of catheter ablation | Experimental | 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. |
|
| No analysis of coronary CT angiography and CAC scoring at the time of catheter ablation | No Intervention | Patients in the control group will follow the current standard of care prior to ablation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablation | Diagnostic Test | Analysis of coronary CT angiography and CAC scoring and initiation of relevant derived treatment at the time of catheter ablation. |
| 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 |
| 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 AF burden as registered by the implantable cardiac monitor after ablation | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Between-group difference in the prevalence of coronary artery disease in patients with atrial fibrillation at baseline | 0 | |
| Between group difference in the quality of life of participants as quantified by a validated self-administered questionnaire | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Espersen, MD | Contact | +4551180082 | caroline.espersen@regionh.dk | |
| Tor Biering-Sørensen, MD, PhD, MPH, MSc | Contact | +4528933590 | tor.biering-soerensen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Tor Biering-Sørensen, MD, PhD, MPH, MSc | Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte | Recruiting | Hellerup | Capital Region | 2900 | Denmark |
Please contact the sponsor-investigator in case of any inquiries.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D050197 | Atherosclerosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between-group difference in the number of participants hospitalized for angina pectoris or 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 or other atrial tachyarrythmias after a 3-month blanking period after ablation | Up to 4 years |
| Number of cardioversions, repeat ablations, and new-onset antiarrythmic drug treatment after a 3-month blanking period after catheter ablation. | Up to 4 years |
| The proportion of participants in the active arm that are started or intensified on the following medication following the coronary CT angiography: statins, antithrombotic or antidiabetic medication | 1 month |
| Between-group differences in the proportion of patients that are started or intensified on the following medication within 1 year after the coronary CT angiography: statins, antithrombotic, antidiabetic, or antihypertensive medication. | 1 year |
| Between-group difference in the number of patients compliant with their prescribed medication 1 and 2 years after the coronary CT angiography as assessed based on a self-administered questionnaire | Up to 2 years |
|
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |