Improvement In Left Ventricular Diameter After Closure Of ASD With Fenestrated Patch: A Cross-sectional Study

NCT06139679 | Completed

• 1 other identifier: 1148/110/3/XII/2021
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The presence of pulmonary hypertension (PH) in atrial septal defect (ASD) poses a clinical challenge on whether or not to close the defect. Closing the defect increases the risk of low cardiac output syndrome (LCOS), while leaving the defect open may eventually lead to irreparable shunt reversal, hypoxemia, and death. The implementation of a fenestrated patch may halt LCOS while adding volume to the left heart. Methods: this is an analytical observational study involving patients with ostium secundum defect with PH who were operated on in Dr. Soetomo Hospital between January 2017 and October 2021. The aim of this study is to evaluate the improvement in left ventricular size during both systole and diastole.

Conditions

Atrial Septal Defect

Keywords

Left Ventricle Diameter; Atrial septal defect closure; Fenestrated patch

Outcome Measures

Primary Outcomes (1)

• Improvement in left ventricular diameter during systole and diastole

  The change in left ventricular diameter during both systole and diastole is measured preoperatively and postoperatively

  January 2017 - October 2021

Study Arms (2)

Fenestrated

Patients with ASD who underwent surgical closure of ASD with fenestrated patch

Procedure: ASD closure with fenestrated/non-fenestrated patch

Non-fenestrated

Patients with ASD who underwent surgical closure of ASD with non-fenestrated patch

Procedure: ASD closure with fenestrated/non-fenestrated patch

Interventions

ASD closure with fenestrated/non-fenestrated patch PROCEDURE

A PTFE patch is used to surgically close the interatrial defect. If closure with fenestrated patch is deemed necessary, a small opening is created on the patch

Fenestrated; Non-fenestrated

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ASD secundum with pulmonary hypertension of all age groups who underwent surgical closure of ASD in Dr. Soetomo General Academic Hospital within January 2017 - October 2021

You may qualify if:

• Patients with ASD secundum and pulmonary hypertension with complete preoperative and postoperative echocardiography (LVIDd and LVIDs) data
• Patients with ASD secundum and pulmonary hypertension with complete preoperative but incomplete postoperative echocardiography (LVIDd and LVIDs) data, but willing to present upon invitation to complete missing postoperative data

You may not qualify if:

• Patients with ASD secundum and pulmonary hypertension who are unwilling to participate in the study, or in a condition that prevents the patient to present for echocardiographic evaluation
• Patients with incomplete medical records

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead

Study Sites (1)

Dr. Soetomo General Academic Hospital

Surabaya, East Java, Indonesia

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

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

Study Officials

• Heroe Soebroto

  Department of Thoracic, Cardiac, and Vascular Surgery, Dr. Soetomo General Hospital, Surabaya, Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 18, 2023
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: November 30, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

ID (1)