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CTRI Number  CTRI/2024/04/065177 [Registered on: 03/04/2024] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Improvement in Right Heart Chambers Dimensions After Closure of The Hole in the Heart Chamber Partition Wall  
Scientific Title of Study   Reverse Remodelling of Right Atrium and Ventricle after Transcatheter Device Closure in Adult Patients with Atrial Septal Defects: A Prospective Cohort Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nirmal Ghati 
Designation  Assistant Professor 
Affiliation  Department of Cardiology, All India Institute of Medical Sciences, New Delhi 
Address  Department of Cardiology, Room No 9, Cardiothoracic Centre (CTC), All India Institute of Medical Sciences, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9013860076  
Fax    
Email  nirmalghati@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Nirmal Ghati 
Designation  Assistant Professor 
Affiliation  Department of Cardiology, All India Institute of Medical Sciences, New Delhi 
Address  Department of Cardiology, Room No 9, Cardiothoracic Centre (CTC), All India Institute of Medical Sciences, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9013860076  
Fax    
Email  nirmalghati@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Dr Nirmal Ghati 
Designation  Assistant Professor 
Affiliation  Department of Cardiology, All India Institute of Medical Sciences, New Delhi 
Address  Department of Cardiology, Room No 9, Cardiothoracic Centre (CTC), All India Institute of Medical Sciences, Ansari Nagar, New Delhi

South West
DELHI
110029
India 
Phone  9013860076  
Fax    
Email  nirmalghati@aiims.edu  
 
Source of Monetary or Material Support  
AIIMS Early Career Intramural Project Fund, Research Section, AIIMS, Ansari Nagar, New Delhi -110029 
 
Primary Sponsor  
Name  AIIMS Delhi Research Section 
Address  All India Institute of Medical Sciences, New Delhi, Research Section, Ansari Nagar, New Delhi 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nirmal Ghati  All India Institute of Medical Sciences, New Delhi  Department of Cardiology, CNC building 7th floor, Room 9, AIIMS, Ansari Nagar, New Delhi -110029
South West
DELHI 		 9013860076

nirmalghati@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (AIIMS, Delhi)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q211||Atrial septal defect,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in interstitial fibrosis level of right atrium and ventricle after ASD device closure as assessed by cardiac magnetic resonance imaging (MRI)  One year follow up 
 
Secondary Outcome  
Outcome  TimePoints 
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
 
 
Target Sample Size   Total Sample Size="73"
Sample Size from India="73" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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. 

 
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