Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT06308094
Status:
RECRUITING
Last Update Posted:
2025-04-13
First Post:
2024-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
320-detector Computed Tomography to Assess Myocardial Extracellular Volume Fraction in Patients With Atrial Fibrillation Before AF Ablation.
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: