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Improvement in Right Heart Chambers Dimensions After Closure of The Hole in the Heart Chamber Partition Wall

Reverse Remodelling of Right Atrium and Ventricle after Transcatheter Device Closure in Adult Patients with Atrial Septal Defects: A Prospective Cohort Study - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065177
Enrollment
73
Registered
2024-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q211- Atrial septal defect

Interventions

Intervention1: Nil: Nil

Sponsors

AIIMS Delhi Research Section
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Change in echocardiographic parameters of cardiac remodeling including â?? volume status, function, and strain pattern of right atrium and right ventricle after ASD device closureTimepoint: 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 levelTimepoint: 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

Countries

India

Contacts

Public ContactDr Nirmal Ghati

Department of Cardiology, All India Institute of Medical Sciences, New Delhi

nirmalghati@aiims.edu9013860076

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026