320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.

NCT06308094 | Recruiting

• 1 other identifier: IRB00429859
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

catheter ablation; ECV; Prognosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Post procedure up to 90 days

Secondary Outcomes (2)

• Change in Ejection Fraction

  Post procedure up to 90 days

• Quality of Life as assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT)

  Baseline, Post procedure up to 90 days

Study Arms (1)

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.

Diagnostic Test: CT

Interventions

CT DIAGNOSTIC_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)

Afib with ECV measurement

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konstantinos Aronis, MD, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantinos Aronis, MD PHD

CONTACT

2017169226; karonis1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Two independent blinded trained readers will detect, interpret and quantify interstitial fibrosis using CT images, to ascertain intra- and inter-observer variability. The readers will determine the region of interest (ROI), myocardial and blood pool attenuation values in the pre-contrast and 5 minutes delayed acquisition.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: April 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)