Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Atrial 3D late gadolinium enhancement.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease, Fibrosis Myocardial, Fibrosis; Heart. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Total atrial fibrosis content from 3D-LGE-CMR [Time frame: 1 year]
Secondary outcome measures (2)
- Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map. [Time frame: 2 years]
- Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Publications
- Bouchardy J, Therrien J, Pilote L, Ionescu-Ittu R, Martucci G, Bottega N, Marelli AJ. Atrial arrhythmias in adults with congenital heart disease. Circulation. 2009 Oct 27;120(17):1679-86. doi: 10.1161/CIRCULATIONAHA.109.866319. Epub 2009 Oct 12. PMID 19822808
- Labombarda F, Hamilton R, Shohoudi A, Aboulhosn J, Broberg CS, Chaix MA, Cohen S, Cook S, Dore A, Fernandes SM, Fournier A, Kay J, Macle L, Mondesert B, Mongeon FP, Opotowsky AR, Proietti A, Rivard L, Ting J, Thibault B, Zaidi A, Khairy P; AARCC. Increasing Prevalence of Atrial Fibrillation and Permanent Atrial Arrhythmias in Congenital Heart Disease. J Am Coll Cardiol. 2017 Aug 15;70(7):857-865. PMID 28797355
- Akoum N, Fernandez G, Wilson B, Mcgann C, Kholmovski E, Marrouche N. Association of atrial fibrosis quantified using LGE-MRI with atrial appendage thrombus and spontaneous contrast on transesophageal echocardiography in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2013 Oct;24(10):1104-9. doi: 10.1111/jce.12199. Epub 2013 Jul 11. PMID 23844972
- Marrouche NF, Wilber D, Hindricks G, Jais P, Akoum N, Marchlinski F, Kholmovski E, Burgon N, Hu N, Mont L, Deneke T, Duytschaever M, Neumann T, Mansour M, Mahnkopf C, Herweg B, Daoud E, Wissner E, Bansmann P, Brachmann J. Association of atrial tissue fibrosis identified by delayed enhancement MRI and atrial fibrillation catheter ablation: the DECAAF study. JAMA. 2014 Feb 5;311(5):498-506. doi: 10. PMID 24496537
- Chelu MG, King JB, Kholmovski EG, Ma J, Gal P, Marashly Q, AlJuaid MA, Kaur G, Silver MA, Johnson KA, Suksaranjit P, Wilson BD, Han FT, Elvan A, Marrouche NF. Atrial Fibrosis by Late Gadolinium Enhancement Magnetic Resonance Imaging and Catheter Ablation of Atrial Fibrillation: 5-Year Follow-Up Data. J Am Heart Assoc. 2018 Dec 4;7(23):e006313. doi: 10.1161/JAHA.117.006313. PMID 30511895
- King JB, Azadani PN, Suksaranjit P, Bress AP, Witt DM, Han FT, Chelu MG, Silver MA, Biskupiak J, Wilson BD, Morris AK, Kholmovski EG, Marrouche N. Left Atrial Fibrosis and Risk of Cerebrovascular and Cardiovascular Events in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Sep 12;70(11):1311-1321. doi: 10.1016/j.jacc.2017.07.758. PMID 28882227
- Chubb H, Aziz S, Karim R, Sohns C, Razeghi O, Williams SE, Whitaker J, Harrison J, Chiribiri A, Schaeffter T, Wright M, O'Neill M, Razavi R. Optimization of late gadolinium enhancement cardiovascular magnetic resonance imaging of post-ablation atrial scar: a cross-over study. J Cardiovasc Magn Reson. 2018 May 3;20(1):30. doi: 10.1186/s12968-018-0449-8. PMID 29720202
- Rivas-Gandara N, Dos-Subira L, Francisco-Pascual J, Rodriguez-Garcia J, Pijuan-Domenech A, Benito B, Valente F, Pascual-Gonzalez G, Santos-Ortega A, Miranda B, Perez-Rodon J, Ribera-Sole A, Burcet-Rodriguez G, Roses-Noguer F, Gordon B, Rodriguez-Palomares J, Ferreira-Gonzalez I. Substrate characterization of the right ventricle in repaired tetralogy of Fallot using late enhancement cardiac magneti PMID 34098087
Identifiers
NCT: NCT05241418 · P00040666