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Trials / Recruiting

RecruitingNCT05241418

Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

Status
Recruiting
Phase
Study type
Observational
Enrollment
50 (estimated)
Sponsor
Boston Children's Hospital · Academic / Other
Sex
All
Age
13 Years
Healthy volunteers
Not accepted

Summary

In this research study the investigators want to learn more about how well the investigators can visualize scar tissue in the heart by MRI. In patients with congenital heart disease who need a procedure in the electrophysiology laboratory, how the MRI findings match the findings in the electrophysiology laboratory is not known. This study works to answer these questions. Participants will undergo a cardiac MRI as part of the routine clinical care that was ordered by their doctors and additional imaging by cardiac MRI will be performed.

Detailed description

Atrial arrhythmias including intra-atrial reentrant tachycardia (IART) and atrial fibrillation (AF) routinely develop after surgical repair of congenital heart disease (CHD), contributing to heart failure exacerbation, increased hospital resource use, and reduced health-related quality of life. The combination of atriotomy scars, intra-cardiac suture lines, and chronic pressure or volume overload from residual lesions creates the necessary milieu of heterogeneous atrial fibrosis capable of supporting wavefront reentry. While catheter ablation has become a primary tool in the management of IART and AF, long-term ablation outcomes have stagnated over the preceding decade despite advances in mapping and ablative technologies. Left atrial (LA) fibrosis analysis using 3-dimensional (3D) late gadolinium enhancement (LGE) cardiac magnetic resonance imaging (CMR) has shown utility in the management of adults with structurally normal hearts and atrial fibrillation (AF), having associations with endocardial bipolar voltage amplitude, likelihood of maintenance of sinus rhythm after ablation, and thromboembolic risk. Excellent reproducibility of LA fibrosis quantification has been demonstrated in adults with structurally normal hearts and AF. To date, the use of 3D LGE in CHD has been limited to the ventricles. Prior studies have described altered LA function in adolescent and young adult patients with rTOF. Additionally, right atrial (RA) functional abnormalities have also been described in patients with rTOF. No prior studies have attempted to validate this technology in the atrium of patients with congenital heart disease. Our studies aims to investigate the reproducibility of atrial fibrosis quantification by cardiac MRI and may provide insights to correlations with voltage mapping in the electrophysiology laboratory.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTAtrial 3D late gadolinium enhancementWe will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria.

Timeline

Start date
2022-03-23
Primary completion
2026-06-30
Completion
2029-06-30
First posted
2022-02-15
Last updated
2025-02-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05241418. Inclusion in this directory is not an endorsement.

Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease (NCT05241418) · Clinical Trials Directory