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A study to compare two surgical techniques Single Patch versus Two Patches for repairing a complex heart defect present at birth in children

Randomized Controlled Trial comparing outcomes of Modified Single versus Double Patch Repair of Complete AVSD A Pilot Approach - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109355
Enrollment
30
Registered
2026-04-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: Q212- Atrioventricular septal defect

Interventions

Intervention1: MODIFIED SINGLE PATCH REPAIR OF COMPLETE AVSD: A Single Patch is used to close both the Atrial Septal Defect and the Ventricular Septal Defect, with the Left Atrioventricular Valve Leaf

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All infants and children diagnosed with Complete Atrioventricular Septal Defect (AVSD) who are scheduled for primary surgical repair at the Department of Cardiothoracic and Vascular Surgery, AIIMS, New Delhi, will be included. Written informed consent from the parent or legally acceptable representative, along with assent from children aged 7 to 18 years where applicable, must be obtained prior to enrolment.

Exclusion criteria

Exclusion criteria: Patients with additional complex cardiac anomalies requiring concurrent corrective procedures, such as Total Anomalous Pulmonary Venous Connection (TAPVC), Aortic Arch abnormalities, or Tetralogy of Fallot (TOF), will be excluded. Patients with a history of previous cardiac surgery will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To assess improvements in cardiac function and valve competence over time. Timepoint: -Echocardiographic assessment of degree of AV Valve Regurgitation, Residual Shunts and LVOT Obstruction at discharge and during follow-up in intervals of 1, 3 and 6 months. -To determine Arrythmias and the need of Pacemaker through ECG at discharge and during follow-up in intervals of 1, 3 and 6 months.—

Secondary

MeasureTime frame
To compare Intraoperative parameters between the two techniques.Timepoint: Cardiopulmonary bypass (CPB) time -Aortic cross-clamp time -Total operative time ;To evaluate differences in recovery and resource utilizationTimepoint: -Duration of ICU stay -Total hospital length of stay -Time to extubation and mobilization ;: To compare the overall safety and efficacy of the modified single-patch versus double-patch technique in the repair of complete AVSD.Timepoint: -Early postoperative mortality within 30 days of surgery. -Reintervention rates—

Countries

India

Contacts

Public ContactMonika Behera

All India Institute of Medical Sciences New Delhi

vdeva@hotmail.com9899623016

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026