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Completed

NCT Number: NCT07132593

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

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.

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Key information

Age range

Up to 14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pediatric Cardiac Surgery Center, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ventricular reconstruction

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.

Primary outcomes

  1. composite endpoint

    Time frame: up to 5 years

    all-cause mortality or cardiac reoperation

Secondary outcomes

  1. ventricular failure

    Time frame: up to 5 years

    left ventricular ejection fraction (LVEF) < 55% or right ventricular fractional area change (RVFAC) < 45% by echocardiography

  2. ventricular aneurysm

    Time frame: up to 5 years

    newly formed segmental dyskinesia with localized dilation

  3. malignant arrhythmia

    Time frame: up to 5 years

    sustained ventricular tachycardia, ventricular fibrillation, or frequent polymorphic premature ventricular contractions requiring medical intervention

  4. Heart block

    Time frame: up to 5 years

    any new onset of high-degree atrioventricular block (Mobitz II or complete AVB), as well as complete left bundle branch block (CLBBB) by ECG

  5. severe perioperative complications

    Time frame: before discharge

    including low cardiac output syndrome [cardiac index < 2.0 L/(min·m2)], delayed sternal closure, prolonged invasive mechanical ventilation (≥ 7 days) and need for extra-corporeal membrane oxygenation (ECMO)

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2025
First posted
Aug 20, 2025
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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