Atrial FibrillationFIBCAGNCT05978388
Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation
A study testing Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablation in people with Atrial Fibrillation, run by Tor Biering-Sørensen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Mar 2024to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Capital Region, 2900
Caroline Espersen, MD, +4551180082, caroline.espersen@regionh.dk
Tor Biering-Sørensen, MD, PhD, MPH, MSc, +4528933590, tor.biering-soerensen@regionh.dk
About this study
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.
Read the detailed description
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:
- If they have paroxysmal atrial fibrillation, the participants will be randomized 1:1 to either pulmonary vein isolation (PVI) or PVI plus posterior wall isolation (FIBCAG-PAF).
- If they have persistent atrial fibrillation, the participants will be randomized 1:1 to either PVI or PVI plus posterior wall isolation, mitral isthmus block, cavotricuspid isthmus block and intercaval linear ablation (FIBCAG-PeAF).
- If they are undergoing reablation, the participants will be randomized 1:1 to either PVI or PVI plus posterior wall isolation, mitral isthmus block, cavotricuspid isthmus block and intercaval linear ablation (FIBCAG-Redo).
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablation
- Keywords
- Coronary Artery Disease, Coronary Computed Tomography Angiography, Atrial Fibrillation, Ischemic heart disease, Catheter Ablation, Atherosclerosis, Cardiovascular Diseases, Randomized Controlled Trial, Statins
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease, Myocardial Ischemia, Atherosclerosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablationDiagnostic test
Analysis of coronary CT angiography and CAC scoring and initiation of relevant derived treatment at the time of catheter ablation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in time to first recurrence of atrial tachyarrhythmia lasting >30 seconds between 91 days after ablation and end of follow-up.
Measured: Up to 4 years
Secondary outcomes (10)
Between-group difference in time to first documented occurrence of other arrhythmias after ablation
Measured: Up to 4 years
Between-group difference in AF burden as registered by the implantable cardiac monitor after ablation
Measured: Up to 4 years
Between-group difference in the number of participants hospitalized for angina pectoris or acute coronary syndrome after ablation
Measured: Up to 4 years
Between-group difference in the incidence of acute myocardial infarction after ablation
Measured: Up to 4 years
Between-group difference in the number of patients undergoing revascularization procedures after ablation
Measured: Up to 4 years
Between-group difference in the number of deaths due to cardiovascular disease after ablation
Measured: Up to 4 years
Between-group difference in incidence of stroke after ablation
Measured: Up to 4 years
Between-group difference in incidence of heart failure or heart failure hospitalization after ablation
Measured: 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
Measured: Up to 4 years
Number of cardioversions, repeat ablations, and new-onset antiarrythmic drug treatment after a 3-month blanking period after catheter ablation.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start26 Mar 2024
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
- Investigators
- Tor Biering-Sørensen, MD, PhD, MPH, MSc, Study chair, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978388
- Sponsor's protocol ID
- FIBCAG
- Acronym
- FIBCAG
- Status last verified
- Jun 2024
- First submitted
- 21 Jul 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please contact the sponsor-investigator in case of any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography AngioGraphy Prior to Catheter Ablation in Patients With Atrial FIBrillation
- ClinicalTrials.gov ID
- NCT05978388
- Acronym / sponsor ID
- FIBCAG / FIBCAG
- Conditions
- Atrial Fibrillation
- Keywords
- Coronary Artery Disease, Coronary Computed Tomography Angiography, Atrial Fibrillation, Ischemic heart disease, Catheter Ablation, Atherosclerosis, Cardiovascular Diseases, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- If they have paroxysmal atrial fibrillation, the participants will be randomized 1:1 to either pulmonary vein isolation (PVI) or PVI plus posterior wall isolation (FIBCAG-PAF).
- If they have persistent atrial fibrillation, the participants will be randomized 1:1 to either PVI or PVI plus posterior wall isolation, mitral isthmus block, cavotricuspid isthmus block and intercaval linear ablation (FIBCAG-PeAF).
- If they are undergoing reablation, the participants will be randomized 1:1 to either PVI or PVI plus posterior wall isolation, mitral isthmus block, cavotricuspid isthmus block and intercaval linear ablation (FIBCAG-Redo).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analysis of coronary CT angiography and CAC scoring at the time of catheter ablation | Experimental | Diagnostic Test: Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablationBased 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablationAnalysis of coronary CT angiography and CAC scoring and initiation of relevant derived treatment at the time of catheter ablation. | Diagnostic test | Analysis of coronary CT angiography and CAC scoring at the time of catheter ablation |
Primary outcome
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
10 secondary outcomes
Between-group difference in time to first documented occurrence of other arrhythmias after ablation
Time frame: Up to 4 years
Between-group difference in AF burden as registered by the implantable cardiac monitor after ablation
Time frame: Up to 4 years
Between-group difference in the number of participants hospitalized for angina pectoris or acute coronary syndrome after ablation
Time frame: Up to 4 years
Between-group difference in the incidence of acute myocardial infarction after ablation
Time frame: Up to 4 years
Between-group difference in the number of patients undergoing revascularization procedures after ablation
Time frame: Up to 4 years
Between-group difference in the number of deaths due to cardiovascular disease after ablation
Time frame: Up to 4 years
Between-group difference in incidence of stroke after ablation
Time frame: Up to 4 years
Between-group difference in incidence of heart failure or heart failure hospitalization after ablation
Time frame: 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
Time frame: Up to 4 years
Number of cardioversions, repeat ablations, and new-onset antiarrythmic drug treatment after a 3-month blanking period after catheter ablation.
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: Yes. Please contact the sponsor-investigator in case of any inquiries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tor Biering-Sørensen, MD, PhD, MPH, MSc study chair
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of coronary CT Angiography and CAC scoring at the time of catheter ablation in people with Atrial Fibrillation, run by Tor Biering-Sørensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Espersen, MD (+4551180082, caroline.espersen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.