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

NCT05978388 | Recruiting

• 1 other identifier: FIBCAG
• Study Type: interventional
• Target: 852
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Coronary Artery Disease; Coronary Computed Tomography Angiography; Atrial Fibrillation; Ischemic heart disease; Catheter Ablation; Atherosclerosis; Cardiovascular Diseases; Randomized Controlled Trial; Statins

Outcome Measures

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.

  Up to 4 years

Secondary Outcomes (10)

• 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

• 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

Other Outcomes (5)

• 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

• 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

Study Arms (2)

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.

Diagnostic Test: Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablation

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.

Interventions

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.

Analysis of coronary CT angiography and CAC scoring at the time of catheter ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tor Biering-Sørensen: lead

Study Sites (1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

Central Study Contacts

Caroline Espersen, MD

CONTACT

+4551180082; caroline.espersen@regionh.dk

Tor Biering-Sørensen, MD, PhD, MPH, MSc

CONTACT

+4528933590; tor.biering-soerensen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Head of Center for Translational Cardiology and Pragmatic Randomized Trials

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 7, 2023
• Study Start: March 26, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

DK (1)