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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age over 18 years.

Referral for catheter ablation treatment (excluding AV-junction ablation) for atrial fibrillation (both paroxysmal and persistent atrial fibrillation) 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.

Disqualifiers

Known atherosclerotic cardiovascular disease (ASCVD).

Ongoing treatment with statins.

Contraindications for coronary CT angiography, e.g. contrast allergy

Recent coronary CT angiography including CAC-score without positive findings <3 years prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

852 Participants
are divided into 2 treatment groups
Group A: Analysis of coronary CT angiography and CAC scoring at the time of catheter ablationExperimental treatment 1 intervention
Group B: No analysis of coronary CT angiography and CAC scoring at the time of catheter ablationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Between-group difference in time to first recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up.

Time frame
Up to 4 years

Secondary outcomes

1

Between-group difference in time to first documented occurrence of other arrhythmias after ablation

Time frame
Up to 4 years
2

Between-group difference in AF burden as registered by the implantable cardiac monitor after ablation

Time frame
Up to 4 years
3

Between-group difference in the number of participants hospitalized for angina pectoris or acute coronary syndrome after ablation

Time frame
Up to 4 years
4

Between-group difference in the incidence of acute myocardial infarction after ablation

Time frame
Up to 4 years

Other outcomes

1

Between-group difference in the prevalence of coronary artery disease in patients with atrial fibrillation at baseline

Time frame
0
2

Between group difference in the quality of life of participants as quantified by a validated self-administered questionnaire

Time frame
1 year
3

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

Time frame
1 month
4

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.

Time frame
1 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution