Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Those with self-reported anxiety or claustrophobia and/or the presence of a permanent pacemaker or implantable cardioverter defibrillator will be excluded.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Atrial 3D late gadolinium enhancement
Diagnostic testWe will use cardiac MRI to take a picture of the atria. This picture will be used to identify scar tissue within the atria.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients with congenital heart disease undergoing a cardiac MRI with Gadolinium1 intervention
Trial outcomes
Primary outcomes
1
Total atrial fibrosis content from 3D-LGE-CMR
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.
Time frame
1 yearSecondary outcomes
1
Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map.
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.
Time frame
2 years2
Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov