A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma

NCT ID: NCT07132593

Last Updated: 2025-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2025-07-31

Brief Summary

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This study was a retrospective descriptive case series analyzing outcomes of a novel surgical approach This study aimed to evaluate a modified surgical technique-called the Sandwich Procedure-for reconstructing the heart after resection of cardiac fibromas in children. Cardiac fibroma is a rare benign tumor that can compress vital cardiac structures and cause serious symptoms such as arrhythmia, heart failure, or obstruction of blood flow. Surgical removal is often required, but large tumors may leave defects in the heart wall that are challenging to repair, especially in young children.

The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding. This retrospective, observational study includes pediatric patients who underwent this procedure between 2018 and 2023. We report on its surgical feasibility, short- and mid-term outcomes, and potential benefits in preserving cardiac function.

Detailed Description

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Conditions

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Cardiac Tumor

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Surgical group

Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure.

ventricular reconstruction

Intervention Type PROCEDURE

The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding.

Interventions

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ventricular reconstruction

The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* underwent cardiac tumor resection
* underwent ventricular reconstruction with the Sandwich Procedure

Exclusion Criteria

* the final pathological diagnosis indicated other than cardiac fibroma
* the final pathological diagnosis indicated metastatic tumors
* incomplete clinical or follow-up data
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pediatric Cardiac Surgery Center, Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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T2024-ZX007-1

Identifier Type: -

Identifier Source: org_study_id

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