Recruiting

Computed Tomography

Sponsor:

Johns Hopkins University

Code:

NCT06308094

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

CT

Study Details

Brief 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. 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.

Conditions

Atrial Fibrillation

Study ID

NCT06308094

Start date

Apr 10, 2025

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Afib with ECV measurement

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.

Interventions

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 measure

  • Recurrence of Atrial Fibrillation [ Time Frame: Post procedure up to 90 days ]
  • Occurrence of ER visits, hospitalizations for cardiovascular causes [ Time Frame: Post procedure up to 90 days ]

Central Contacts and Locations

Central contacts

Konstantinos Aronis, MD PHD

2017169226karonis1@jhmi.edu

Locations

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • catheter ablation
  • ECV
  • Prognosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-04-13.