Reverse Remodelling of Right Atrium and Ventricle after Transcatheter Device Closure in Adult Patients with Atrial Septal Defects: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Change in interstitial fibrosis level of right atrium and ventricle after ASD device closure as assessed by cardiac magnetic resonance imaging (MRI)
研究概览
简要总结
Atrial septal defect is one of the most common congenital heart defects in adults. Moderate to large ASD results in significant left to right shunt causing volume and pressure overload of right heart chambers. In long-standing defects, this chronic wall stretch of the right atrium and ventricle leads to up signaling of profibrotic cascades. A recent MRI study has shown significant interstitial fibrosis in the right atrium in adults with uncorrected ASD. Patients with atrial tachyarrhythmia and ASD have greater fibrosis levels suggesting prognostic significance of the fibrosis extent. Till date, there are no studies on change in RA/RV fibrosis post-device closure of ASD—also, long-term CMR data on atrial and ventricular remodeling after ASD closure is limited. No study has evaluated the change in the prevalence of atrial tachyarrhythmias with a change in RA/RV fibrosis. The present study, thus, seeks to prospectively characterize the changes in cardiac volumes and RA/RV fibrosis using CMR after 12 months of transcatheter device closure of ASD and to investigate whether a change in RA/RV fibrosis is associated with a change in the prevalence of atrial arrhythmias.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Isolated OS-ASD with sufficient rims(more than 5mm
- •Net left to right shunt more than 1.5:1
- •RA and RV volume overload
- •Pulmonary vascular resistance (PVR) is less than one-third of Systemic vascular resistance (SVR)
- •No cyanosis at rest or during exercise
- •Age more than 18 years and less than 70 years.
- •Willing to give informed consent.
排除标准
- •ASD not amenable to device closure i.
- •Ostium secundum ASD with insufficient rims (less than 5mm) ii.
- •ASDs other than Ostium secundum ASD iii.
- •ASD is associated with other congenital anomalies.
- •Eisenmenger syndrome
- •Patient is undergoing surgical patch closure of ASD.
- •Contraindications for MRI a.
- •MRI incompatible implants b.
- •Claustrophobia c.
- •Renal insufficiency d.
- •Pregnant women
- •Not willing to give consent.
结局指标
主要结局
Change in interstitial fibrosis level of right atrium and ventricle after ASD device closure as assessed by cardiac magnetic resonance imaging (MRI)
时间窗: One year follow up
次要结局
- Change in echocardiographic parameters of cardiac remodeling including – volume status, function, and strain pattern of right atrium and right ventricle after ASD device closure(One year follow up)
- Relationship between different pre device closure demographic, cardiac variables (like- age, gender, ASD size, cardiac volumes, fibrosis levels, Cath study parameters) and post device closure cardiac reverse remodeling including fibrosis level(One year follow up)
- Clinical significance of post atrial device closure cardiac reverse remodeling including change in fibrosis level in terms of cardiac arrhythmia(One year follow up)
研究者
Dr Nirmal Ghati
Department of Cardiology, All India Institute of Medical Sciences, New Delhi