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临床试验/NCT05241418
NCT05241418招募中不适用

Atrial Late Gadolinium Enhancement in Patients with Repaired Congenital Heart Disease

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Total atrial fibrosis content from 3D-LGE-CMR

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Total atrial fibrosis content from 3D-LGE-CMR

时间窗: 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.

次要结局

  • Sustained atrial arrhythmia, defined as IART/AF lasting >30 seconds detected on ECG, ambulatory monitor, or inpatient telemetry(5 years)
  • Total atrial fibrosis content from catheter-derived endocardial bipolar voltage map.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Castellanos

Assistant Professor of Pediatrics

Boston Children's Hospital

研究点 (1)

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