Transcatheter Versus Surgical Closure of Ventricular Septal Defect: A Comparative Study

NCT05306483 | Completed DMC

• 1 other identifier: MS97/2021
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare Safety, efiicacy and clinical effects of surgical versus transcatheter closure of ventricular septal defect (VSD ). The outcome of interest is success rate, residual shunts, effect on tricuspid and aortic valves, need for blood transfusion, length of hospital and intensive care unit ( ICU ) stay, complications especially complete heart block, affection of kidney functions due to the procedure length caused by Cardiopulmonary bypass in case of surgical group or by the dye used in the group of transcatheter closure.

Conditions

Heart Defects, Congenital

Outcome Measures

Primary Outcomes (1)

• Rate of Transthoracic Echocardiography residual ventricular septal defect shunts

  two-dimensional Transthoracic Echocardiography for Detection of persistent residual Ventricular septal defect shunt flow - physiological parameter

  One year

Secondary Outcomes (4)

• Incidence of Transthoracic Echocardiography tricuspid and aortic valves regurgitation detect

  One year

• % of patients with need for blood transfusion

  One week postoperative

• length of hospital or ICU stay

  One month

• Rate of Electrocardiogram complete heart block

  One month

Study Arms (2)

Ventricular septal defect closure surgery

ACTIVE COMPARATOR

Surgical closure would be done under general anesthesia, hypothermic cardiopulmonary bypass and cardioplegic arrest. Chest would be opened through standard median sternotomy Surgical techniques would be determined according to the nature of every defect and includes direct closure, patch closure which involves the use of autologous pericardium; however, polyethylene terephthalate (Dacron; C.R Bard, Haverhill, MA) and expanded polytetrafluoroethylene (Gore-Tex; W.L. Gore \& Associates, Inc.,AZ) may be occasionally used. These patches are held with continuous or interrupted sutures. Direct closure (without a patch may be done for the very small defects.Most VSDs would be repaired through right atriotomy to avoid the the undesirable effects of the trans ventricular approach.

Procedure: Ventricular septal defect closure surgery

catheter closure of ventricular septal defect

ACTIVE COMPARATOR

Under general anesthesia, patients will be fully heparinized (100IU/Kg) with follow up by activated clotting time. IntraoperativeTEE will be done for more detailed assessment of the defect size, relation to the surrounding structures especially the distance from the tricuspid and the aortic valve to guide the procedure and for proper assessment after device positioning yet before its release. Left ventricular angiogram will be done in LAO 60, cranial 30 projection to define location and size of the defect. Accordingly, proper selection of the device siz.

Procedure: Ventricular septal defect closure catheter

Interventions

Ventricular septal defect closure surgery PROCEDURE

Ventricular septal defect closure surgery

Also known as: patients undergoing surgical VSD closure

Ventricular septal defect closure surgery

Ventricular septal defect closure catheter PROCEDURE

Catheter closure of VSD

Also known as: Patients undergoing VSD trans catheter

catheter closure of ventricular septal defect

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ventricular septal defect: All patients who have congenital VSD which require intervention and accepting the selected measure of intervention. Surgery closure for Perimembranous VSD which is not suitable for catheter closure, muscular VSD. Catheter closure for Perimembranous VSD with at least 4 mm distal from aortic valve, mid muscular, anterior muscular.
• Age: Pediatric age group with minimum age of 10 months to 18 years old.
• Gender: both males and females.
• Intervention classification: Elective.
• NYHA classification: I - III
• weight more than 8 Kg.
• left to right shunt with Qp/Qs more than 1.5.

You may not qualify if:

• Non-congenital VSD.
• severe pulmonary hypertension with right to left shunt.
• ischemic stroke
• hemorrhage stroke
• systemic thromboembolism
• heart failure
• rheumatic heart disease
• cardiac valvular abnormalities
• infective endocarditis
• high degree atrioventricular block
• atrial fibrillation, atrial flutter
• paroxysmal supraventricular tachycardia
• endocardial cushing syndome,
• Ebstein's anomaly
• hemodynamically significant atrial septal defect

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hamdy Singab

Cairo, 11517, Egypt

Location

Related Publications (14)

• Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.

  PMID: 12084585 RESULT

• Alahmadi MH, Oliver TI. Ventricular Septal Defect. 2024 Oct 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470330/

  PMID: 29261884 RESULT

• Mongeon FP, Burkhart HM, Ammash NM, Dearani JA, Li Z, Warnes CA, Connolly HM. Indications and outcomes of surgical closure of ventricular septal defect in adults. JACC Cardiovasc Interv. 2010 Mar;3(3):290-7. doi: 10.1016/j.jcin.2009.12.007.

  PMID: 20298987 RESULT

• LILLEHEI CW, COHEN M, WARDEN HE, VARCO RL. The direct-vision intracardiac correction of congenital anomalies by controlled cross circulation; results in thirty-two patients with ventricular septal defects, tetralogy of Fallot, and atrioventricularis communis defects. Surgery. 1955 Jul;38(1):11-29. No abstract available.

  PMID: 14396676 RESULT

• Lock JE, Block PC, McKay RG, Baim DS, Keane JF. Transcatheter closure of ventricular septal defects. Circulation. 1988 Aug;78(2):361-8. doi: 10.1161/01.cir.78.2.361.

  PMID: 3396173 RESULT

• Hijazi ZM, Hakim F, Haweleh AA, Madani A, Tarawna W, Hiari A, Cao QL. Catheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: initial clinical experience. Catheter Cardiovasc Interv. 2002 Aug;56(4):508-15. doi: 10.1002/ccd.10292.

  PMID: 12124963 RESULT

• Holzer R, Balzer D, Cao QL, Lock K, Hijazi ZM; Amplatzer Muscular Ventricular Septal Defect Investigators. Device closure of muscular ventricular septal defects using the Amplatzer muscular ventricular septal defect occluder: immediate and mid-term results of a U.S. registry. J Am Coll Cardiol. 2004 Apr 7;43(7):1257-63. doi: 10.1016/j.jacc.2003.10.047.

  PMID: 15063439 RESULT

• Sullivan ID. Transcatheter closure of perimembranous ventricular septal defect: is the risk of heart block too high a price? Heart. 2007 Mar;93(3):284-6. doi: 10.1136/hrt.2006.103671. Epub 2006 Oct 11.

  PMID: 17035508 RESULT

• Masura J, Gao W, Gavora P, Sun K, Zhou AQ, Jiang S, Ting-Liang L, Wang Y. Percutaneous closure of perimembranous ventricular septal defects with the eccentric Amplatzer device: multicenter follow-up study. Pediatr Cardiol. 2005 May-Jun;26(3):216-9. doi: 10.1007/s00246-005-1003-7.

  PMID: 16082578 RESULT

• Saxena A, Relan J, Agarwal R, Awasthy N, Azad S, Chakrabarty M, Dagar KS, Devagourou V, Dharan BS, Gupta SK, Iyer KS, Jayranganath M, Joshi R, Kannan B, Katewa A, Kohli V, Kothari SS, Krishnamoorthy KM, Kulkarni S, Kumar RM, Kumar RK, Maheshwari S, Manohar K, Marwah A, Mishra S, Mohanty SR, Murthy KS, Rao KN, Suresh PV, Radhakrishnan S, Rajashekar P, Ramakrishnan S, Rao N, Rao SG, Chinnaswamy Reddy HM, Sharma R, Shivaprakash K, Subramanyan R, Kumar RS, Talwar S, Tomar M, Verma S, Vijaykumar R. Indian guidelines for indications and timing of intervention for common congenital heart diseases: Revised and updated consensus statement of the Working group on management of congenital heart diseases. Ann Pediatr Cardiol. 2019 Sep-Dec;12(3):254-286. doi: 10.4103/apc.APC_32_19.

  PMID: 31516283 RESULT

• Kouchoukos NT, Blackstone EH, Kirklin JW. Surgical implications of pulmonary hypertension in congenital heart disease. Adv Cardiol. 1978;(22):225-31. doi: 10.1159/000401033.

  PMID: 619518 RESULT

• JULIAN OC, LOPEZ-BELIO M, DYE WS, JAVID H, GROVE WJ. The median sternal incision in intracardiac surgery with extracorporeal circulation; a general evaluation of its use in heart surgery. Surgery. 1957 Oct;42(4):753-61. No abstract available.

  PMID: 13467646 RESULT

• Merrick AF, Lal M, Anderson RH, Shore DF. Management of ventricular septal defect: a survey of practice in the United Kingdom. Ann Thorac Surg. 1999 Sep;68(3):983-8. doi: 10.1016/s0003-4975(99)00689-x.

  PMID: 10509995 RESULT

• Odemis E, Saygi M, Guzeltas A, Tanidir IC, Ergul Y, Ozyilmaz I, Bakir I. Transcatheter closure of perimembranous ventricular septal defects using Nit-Occlud((R)) Le VSD coil: early and mid-term results. Pediatr Cardiol. 2014 Jun;35(5):817-23. doi: 10.1007/s00246-013-0860-8. Epub 2014 Jan 12.

  PMID: 24413836 RESULT

Related Links

• Faculty of medicine, Ain shams university,cairo, Egypt

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The population of our intervention study is divided into two groups of participants receive different interventions. group (A) Patients undergoing surgical VSD closure (control group) group (B) Patients undergoing transcatheter VSD closure.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: April 1, 2022
• Study Start: June 12, 2020
• Primary Completion: March 15, 2021
• Study Completion: June 15, 2021
• Last Updated: April 13, 2022

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)