Atrial FibrillationNCT06308094
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.
A study testing CT in people with Atrial Fibrillation, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2025to 1 Dec 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be at least 21 years old at the time of enrollment.
- Patients must be able to give informed consent.
- Patients with symptomatic paroxysmal/persistent atrial fibrillation (AF).
- Eligible patients must be determined to be suitable candidates for ablation to treat AF by their cardiologist and/or electrophysiologists regardless of this protocol.
- Patients are scheduled to have a pre-procedure cardiac CT upon the discretion of their electrophysiologists
Who cannot join
- Known allergy to iodinated contrast media.
- Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula).
- Patients with a positive urine or serum pregnancy test will be excluded from this study.
- Patients with heart transplantation.
- Patients with polymorphic ventricular tachycardia (VT) or presenting in electrical storm.
- Presence of any other history or condition that the investigator feels would be problematic.
Show all 9Show fewer
- Patient with iodinated contrast administration for other reason 24 hours prior to investigational CT.
- Patients who have a heart pacemaker, metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, mechanical heart valves and prosthetics that contain metal.
- Patients with severe claustrophobia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
About this study
This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies.
Read the detailed description
Atrial Fibrillation (AF) is the most common arrhythmia and is associated with significant healthcare-related expenses. With the aging population, the prevalence of AF is increasing. AF frequently co-exists with heart failure (HF) with reduced (HFrEF) or preserved (HFpEF) ejection fraction. The relationship between AF and HF is complex, and one condition constitutes a risk factor for the other. Myocardial interstitial fibrosis is a hallmark of myocardial remodeling occurring as a consequence of risk factor exposure leading to both AF and heart failure. However, the role of interstitial fibrosis in the prognosis of patients with atrial fibrillation with and without heart failure remains unknown.
AF has a significant impact on patients' well-being and quality of life. In addition to coping with uncomfortable symptoms, individuals with this condition face an increased risk of future adverse events like frailty, stroke, dementia, and all-cause mortality. To address these concerns, many patients opt for procedures such as AF ablation, hoping for a cure. While the results of this procedure show promise, a small percentage of patients who undergo AF ablation may experience a recurrence of the arrhythmia or find that the participant's heart's systolic function does not fully recover. The investigators aim is to investigate whether there is a connection between myocardial fibrosis and poor outcomes following AF ablation.
Cardiac MRI (CMR) has been the gold standard methodology of quantification of interstitial fibrosis. Diffuse interstitial fibrosis can be quantified by extracellular volume (ECV) imaging. CMR-based left ventricular ECV has been associated with adverse outcomes in multiple cardiovascular disease states. However, the availability of CMR is confined only to tertiary centers with expertise. Cardiac CT is an alternative way to detect and quantify interstitial fibrosis by quantification of ECV. CT-derived ECV has been shown in multiple studies to have an excellent correlation with CMR-derived ECV. Cardiac CT is widely available and has a higher spatial resolution. Since as part of the standard pre-ablation routine, patients will undergo a cardiac CT scan to accurately map the anatomy of the participant's heart, investigators ought to measure ECV parameters during this visit.
- Conditions
- Atrial Fibrillation
- Being tested
- CT
- Keywords
- catheter ablation, ECV, Prognosis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTDiagnostic test
Pre-ablation CT is clinically acquired in patients undergoing catheter ablation. This study entails additional acquisition of the left ventricle to assess extracellular volume (ECV)
| Study group | Role | What they receive |
|---|---|---|
| Afib with ECV measurement | Other | patients who are referred for catheter ablation will undergo additional CT acquisition for measurement of ECV to determine if there is any association between ECV expansion and Afib burden. Receives: Diagnostic Test: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of Atrial Fibrillation
Patients will undergo computed tomography (CT) imaging with a total of 4 CT image acquisition (2 clinical and 2 research) During the follow-up visit with the primary electrophysiologist within 90 days after the procedure, the patient will be assessed for recurrence of atrial fibrillation.
Measured: Post procedure up to 90 days
Occurrence of ER visits, hospitalizations for cardiovascular causes
Patients will be assessed for any emergency room visits, or hospitalizations for any cardiovascular causes.
Measured: Post procedure up to 90 days
Secondary outcomes (2)
Change in Ejection Fraction
As a follow-up measure, the patient will proceed to have an echocardiogram to check for improvement in ejection fraction. At the end of the study we we will analyze if there are any correlations between ECV expansion and lack of ejection fraction (EF) improvement.
Measured: Post procedure up to 90 days
Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
Atrial Fibrillation Effect on Quality-of-Life will be used to measure quality of life. The score ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, Post procedure up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start10 Apr 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (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.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Konstantinos Aronis, MD, PhD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308094
- Sponsor's protocol ID
- IRB00429859
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.
- ClinicalTrials.gov ID
- NCT06308094
- Acronym / sponsor ID
- IRB00429859
- Conditions
- Atrial Fibrillation
- Keywords
- catheter ablation, ECV, Prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Mar 2024 (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.
This study explores the relationship between myocardial fibrosis and patient outcomes in Atrial Fibrillation (AF), specifically after catheter ablation. It aims to use Cardiac CT, an accessible tool, to measure left ventricular extracellular volume (ECV) as an indicator of fibrosis. The study will assess if higher ECV levels correlate with increased risks of AF recurrence, hospitalization, and poor cardiac function recovery. Positive findings could make ECV a key factor in deciding AF treatment strategies.
Detailed description
Atrial Fibrillation (AF) is the most common arrhythmia and is associated with significant healthcare-related expenses. With the aging population, the prevalence of AF is increasing. AF frequently co-exists with heart failure (HF) with reduced (HFrEF) or preserved (HFpEF) ejection fraction. The relationship between AF and HF is complex, and one condition constitutes a risk factor for the other. Myocardial interstitial fibrosis is a hallmark of myocardial remodeling occurring as a consequence of risk factor exposure leading to both AF and heart failure. However, the role of interstitial fibrosis in the prognosis of patients with atrial fibrillation with and without heart failure remains unknown.
AF has a significant impact on patients' well-being and quality of life. In addition to coping with uncomfortable symptoms, individuals with this condition face an increased risk of future adverse events like frailty, stroke, dementia, and all-cause mortality. To address these concerns, many patients opt for procedures such as AF ablation, hoping for a cure. While the results of this procedure show promise, a small percentage of patients who undergo AF ablation may experience a recurrence of the arrhythmia or find that the participant's heart's systolic function does not fully recover. The investigators aim is to investigate whether there is a connection between myocardial fibrosis and poor outcomes following AF ablation.
Cardiac MRI (CMR) has been the gold standard methodology of quantification of interstitial fibrosis. Diffuse interstitial fibrosis can be quantified by extracellular volume (ECV) imaging. CMR-based left ventricular ECV has been associated with adverse outcomes in multiple cardiovascular disease states. However, the availability of CMR is confined only to tertiary centers with expertise. Cardiac CT is an alternative way to detect and quantify interstitial fibrosis by quantification of ECV. CT-derived ECV has been shown in multiple studies to have an excellent correlation with CMR-derived ECV. Cardiac CT is widely available and has a higher spatial resolution. Since as part of the standard pre-ablation routine, patients will undergo a cardiac CT scan to accurately map the anatomy of the participant's heart, investigators ought to measure ECV parameters during this visit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afib with ECV measurement | Other | Diagnostic Test: CTpatients who are referred for catheter ablation will undergo additional CT acquisition for measurement of ECV to determine if there is any association between ECV expansion and Afib burden. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be at least 21 years old at the time of enrollment.
- Patients must be able to give informed consent.
- Patients with symptomatic paroxysmal/persistent atrial fibrillation (AF).
- Eligible patients must be determined to be suitable candidates for ablation to treat AF by their cardiologist and/or electrophysiologists regardless of this protocol.
- Patients are scheduled to have a pre-procedure cardiac CT upon the discretion of their electrophysiologists
Key exclusion criteria (9 listed)
- Known allergy to iodinated contrast media.
- Elevated serum creatinine (> 1.5mg/dl) OR calculated creatinine clearance of < 60 ml/min (using the Cockcroft-Gault formula).
- Patients with a positive urine or serum pregnancy test will be excluded from this study.
- Patients with heart transplantation.
- Patients with polymorphic ventricular tachycardia (VT) or presenting in electrical storm.
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 |
|---|---|---|
| CTPre-ablation CT is clinically acquired in patients undergoing catheter ablation. This study entails additional acquisition of the left ventricle to assess extracellular volume (ECV) | Diagnostic test | Afib with ECV measurement |
Primary outcome
Recurrence of Atrial Fibrillation
Time frame: Post procedure up to 90 days
Patients will undergo computed tomography (CT) imaging with a total of 4 CT image acquisition (2 clinical and 2 research) During the follow-up visit with the primary electrophysiologist within 90 days after the procedure, the patient will be assessed for recurrence of atrial fibrillation.
Occurrence of ER visits, hospitalizations for cardiovascular causes
Time frame: Post procedure up to 90 days
Patients will be assessed for any emergency room visits, or hospitalizations for any cardiovascular causes.
2 secondary outcomes
Change in Ejection Fraction
Time frame: Post procedure up to 90 days
Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)
Time frame: Baseline, Post procedure up to 90 days
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 13 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Konstantinos Aronis, MD, PhD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT in people with Atrial Fibrillation, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 9 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 13 Apr 2026. 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 United States. 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 Konstantinos Aronis, MD PHD (2017169226, karonis1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of Atrial Fibrillation (time frame: Post procedure up to 90 days). The study lists 2 primary outcomes in all. 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 13 Apr 2026.