Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT05241418

Conditions

Congenital Heart Disease

Fibrosis Myocardial

Fibrosis; Heart

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

Interventions

Atrial 3D late gadolinium enhancement

Study Details

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.

Conditions

Congenital Heart Disease

Fibrosis Myocardial

Fibrosis; Heart

Study ID

NCT05241418

Start date

Mar 23, 2022

Status verified date

Feb, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Total atrial fibrosis content from 3D-LGE-CMR [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Daniel A Castellanos, MD

6173557769daniel.castellanos@cardio.chboston.org

Edward O'Leary, MD

6173557275Edward.OLeary@cardio.chboston.org

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Daniel A Castellanos, MD

6173557769daniel.castellanos@cardio.chboston.org

Edward O'Leary, MD

6173557275Edward.OLeary@cardio.chboston.org

More Information

Sponsor

Boston Children's Hospital

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • Late gadolinium enhancement
  • 3D late gadolinium enhancement
  • atrial late gadolinium enhancement
  • Cardiac MRI
  • Congenital heart disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2025-02-13.