NCT06308094 · Johns Hopkins University
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
CT
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)
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
- 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.
Where
- Baltimore, Maryland
Collaborators
Canon Medical Systems, USA
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations