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Observational Study on Atrial Scar Tissue in Congenital Heart Disease

This study aims to understand how well a special type of MRI, called Atrial 3D late gadolinium enhancement (LGE), can show scar tissue in the heart's upper chambers (atria) of people with repaired congenital heart disease (a heart problem present from birth). Researchers want to see if the MRI findings match what is found during a procedure in the electrophysiology laboratory. You may be able to join if you are over 13 years old, have congenital heart disease, and are already scheduled for a cardiac MRI with gadolinium as part of your routine care or for pre-ablation planning. The main goal is to measure the total amount of scar tissue in the atria using the 3D-LGE-CMR at one year. The study is currently unclear on its recruitment status and plans to enroll 50 participants.

Study design
This is an observational study, meaning researchers will observe and collect information without providing a specific treatment. It plans to include 50 participants.
What's involved
You would undergo a cardiac MRI as part of your routine clinical care, with additional imaging performed during that same MRI session.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, total atrial fibrosis content, will be measured at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05241418

Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

Recruiting
Not specifiedAges 13+Observational
Boston Children's Hospital
~50 participants
Updated 2025-02-13 on ClinicalTrials.gov
What's tested:Atrial 3D late gadolinium enhancement

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total atrial fibrosis content from 3D-LGE-CMR
Measured over 1 year

Conditions

Congenital Heart Disease
Fibrosis Myocardial
Fibrosis; Heart

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Congenital Heart Disease

NCT05241418

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Boston Children's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Daniel A Castellanos, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Daniel A Castellanos, MD
[email protected]
6173557769
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Total atrial fibrosis content from 3D-LGE-CMR1 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.