Cardiac TumorNCT07132593
A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma
An observational study of Cardiac Tumor, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Cardiac Tumor
- What is being tested?
- ventricular reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: patients underwent cardiac fibroma resection followed by ventricular reconstruction with the Sandwich Procedure at our institution
Who may be able to join
- underwent cardiac tumor resection
- underwent ventricular reconstruction with the Sandwich Procedure
Who cannot join
- the final pathological diagnosis indicated other than cardiac fibroma
- the final pathological diagnosis indicated metastatic tumors
- incomplete clinical or follow-up data
Trial locations and contacts
1 site in 1 country.
China1 site
Pediatric Cardiac Surgery Center, Fuwai Hospital
Beijing, Beijing Municipality, 100037
About this study
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.
- Conditions
- Cardiac Tumor
- Being tested
- ventricular reconstruction
- Keywords
- congenital heart disease, cardiac tumor, surgical technique
- Medical subject headings
- Heart Neoplasms, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ventricular reconstructionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgical group | Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure. Receives: Procedure: ventricular reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite endpoint
all-cause mortality or cardiac reoperation
Measured: up to 5 years
Secondary outcomes (5)
ventricular failure
left ventricular ejection fraction (LVEF) < 55% or right ventricular fractional area change (RVFAC) < 45% by echocardiography
Measured: up to 5 years
ventricular aneurysm
newly formed segmental dyskinesia with localized dilation
Measured: up to 5 years
malignant arrhythmia
sustained ventricular tachycardia, ventricular fibrillation, or frequent polymorphic premature ventricular contractions requiring medical intervention
Measured: up to 5 years
Heart block
any new onset of high-degree atrioventricular block (Mobitz II or complete AVB), as well as complete left bundle branch block (CLBBB) by ECG
Measured: up to 5 years
severe perioperative complications
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)
Measured: before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac TumorStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132593
- Sponsor's protocol ID
- T2024-ZX007-1
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma
- ClinicalTrials.gov ID
- NCT07132593
- Acronym / sponsor ID
- T2024-ZX007-1
- Conditions
- Cardiac Tumor
- Keywords
- congenital heart disease, cardiac tumor, surgical technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical group | – | Procedure: ventricular reconstructionPatients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- patients underwent cardiac fibroma resection followed by ventricular reconstruction with the Sandwich Procedure at our institution
Key inclusion criteria (2 listed)
- underwent cardiac tumor resection
- underwent ventricular reconstruction with the Sandwich Procedure
Key exclusion criteria (3 listed)
- the final pathological diagnosis indicated other than cardiac fibroma
- the final pathological diagnosis indicated metastatic tumors
- incomplete clinical or follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ventricular reconstructionThe 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. | Procedure or surgery | Surgical group |
Primary outcome
composite endpoint
Time frame: up to 5 years
all-cause mortality or cardiac reoperation
5 secondary outcomes
ventricular failure
Time frame: up to 5 years
ventricular aneurysm
Time frame: up to 5 years
malignant arrhythmia
Time frame: up to 5 years
Heart block
Time frame: up to 5 years
severe perioperative complications
Time frame: before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No. The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study.
Related trials for Cardiac Tumor
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingObservational study
3D Versus 2D Strain Echocardiography for Early Detection of Cardiotoxicity During Cancer Therapy
Cancer Related Cardiovascular Toxicity, Anthracycline Related Cardiotoxicity in Breast Cancer
RecruitingObservational study
Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System
Metabolic Disease, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Tumor, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite endpoint (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.