Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

February 10, 2025 updated by: Daniel Castellanos, Boston Children's Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The hospital at which the investigators are based is a referral center for patients with congenital heart disease. These patients sometimes require a cardiac MRI. Patients >13 years old with congenital heart disease referred for CMR and meeting eligibility criteria will be approached for this study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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.
Other Names:
  • Atrial 3D LGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total atrial fibrosis content from 3D-LGE-CMR
Time Frame: 1 year
Atrial 3D-LGE-CMR images will be post-processed using the Circle ADAS 3D software module (Circle Cardiovascular Inc., Calgary, AB, Canada) and analyzed to identify fibrotic tissue. Results are portrayed as 3D-colored maps and as a calculated percentage of atrial fibrosis relative to total atrial surface area. All CMR images will be analyzed by two observers for the calculation of interrater reliability of the percent of atrial LGE. One observer will perform contours twice for the purposes of intra-observer agreement.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map.
Time Frame: 2 years
In patients who have a cardiac MRI and then an electrophysiology study as part of their clinical care, the 3D-CMR image will be compared to the catheter-generated electro-anatomic voltage mapping obtained in the electrophysiology laboratory.
2 years
Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry
Time Frame: 5 years
Following 3D-LGE-CMR acquisition, CMR and clinical data will be entered into a deidentified database to be used for clinical research. After 5 years patients without a prior history of electrophysiology issues will be analyzed prospectively (over a 5 year period) for the development of a sustained atrial arrhythmia using time-to-event analysis.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Daniel A Castellanos, MD, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00040666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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