Improvement in Right Heart Chambers Dimensions After Closure of The Hole in the Heart Chamber Partition Wall
- Conditions
- Health Condition 1: Q211- Atrial septal defect
- Registration Number
- CTRI/2024/04/065177
- Lead Sponsor
- AIIMS Delhi Research Section
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Isolated OS-ASD with sufficient rims(more than 5mm
2. Net left to right shunt more than 1.5:1
3. RA and RV volume overload
4. Pulmonary vascular resistance (PVR) is less than one-third of
Systemic vascular resistance (SVR)
5. Pulmonary artery systolic pressure (PASP) less than 50 percent of
Systolic blood pressure (SBP)
6. No cyanosis at rest or during exercise
7. Age more than 18 years and less than 70 years.
8. Willing to give informed consent.
1. 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.
2. Eisenmenger syndrome
3. Patient is undergoing surgical patch closure of ASD.
4. Contraindications for MRI
a. MRI incompatible implants
b. Claustrophobia
c. Renal insufficiency
d. Pregnant women
5. Not willing to give consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in interstitial fibrosis level of right atrium and ventricle after ASD device closure as assessed by cardiac magnetic resonance imaging (MRI)Timepoint: One year follow up
- Secondary Outcome Measures
Name Time Method Change in echocardiographic parameters of cardiac remodeling including – volume status, function, and strain pattern of right atrium and right ventricle after ASD device closureTimepoint: One year follow up;Clinical significance of post atrial device closure cardiac reverse remodeling including change in fibrosis level in terms of cardiac arrhythmiaTimepoint: One year follow up <br/ ><br>;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 levelTimepoint: One year follow up