Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

NCT ID: NCT05241418

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2029-06-30

Brief 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

Congenital Heart Disease; Fibrosis Myocardial; Fibrosis; Heart

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium

Patients with congenital heart disease who are undergoing a clinically-ordered cardiac MRI and as part of that MRI the contrast agent, Gadolinium, will be administered.

Atrial 3D late gadolinium enhancement

Intervention Type: DIAGNOSTIC_TEST

We will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria.

Interventions

Atrial 3D late gadolinium enhancement

We will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Atrial 3D LGE

Eligibility Criteria

Inclusion Criteria

• Patients >13 years old with congenital heart disease referred for cardiac MRI and receiving gadolinium as part of routine clinical care or for pre-ablation planning will be included.

Exclusion Criteria

• Those with self-reported anxiety or claustrophobia and/or the presence of a permanent pacemaker or implantable cardioverter defibrillator will be excluded.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Daniel Castellanos

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel A Castellanos, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel A Castellanos, MD

Role: CONTACT

daniel.castellanos@cardio.chboston.org

6173557769

Edward O'Leary, MD

Role: CONTACT

Edward.OLeary@cardio.chboston.org

6173557275

Facility Contacts

Daniel A Castellanos, MD

Role: primary

daniel.castellanos@cardio.chboston.org

6173557769

Edward O'Leary, MD

Role: backup

Edward.OLeary@cardio.chboston.org

6173557275

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Other Identifiers

P00040666

Identifier Type: -

Identifier Source: org_study_id