Transposition of Great VesselsNCT05089773
Outcomes of Transposition of the Great Arteries After Arterial Switch Operation
An observational study of Transposition of Great Vessels and Outcome, Fatal, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transposition of Great Vessels, Outcome, Fatal
- What is being tested?
- The arterial switch operation
- Type of treatment
- Surgery or procedure
- How many people
- 1,281 participants
- Where
- 2 sitesChina
- Study dates
- 1 Dec 2019to 30 Apr 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020, regardless of the age, sex, and the anatomy.
Who may be able to join
- Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020.
Who cannot join
- NA.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Children's Hospital of Fudan University
Shanghai, 200000
Shanghai Children's medical center
Shanghai
About this study
Official title: Outcomes of Transposition of the Great Arteries After Arterial Switch Operation: a Dual-center Study
Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA.
Read the detailed description
Transposition of the Great Arteries (TGA) is a relatively rare congenital heart disease and surgical treatment in China was developed in recent 20 years. The outcomes of arterial switch operation (ASO) in TGA in China have not been reported before. This study was designed to offer the experience of surgical treatment of TGA in two major pediatric heart centers affiliated in national children's medical center in China. In this retrospective study, a total of 1281 patients diagnosed with TGA received ASO treatment in Fudan Children's Hospital and Shanghai Children's Medical Center were recruited. Medical records and follow-up data of patients were complete. Patient characteristics and clinical data were obtained through review of the medical records, preoperative echocardiography and cardiac catheterization data, operative notes, and follow up reports. Description of the anatomy was confirmed on the preoperative echocardiogram, with clarification from the operative note as needed. Anatomy of the coronary arteries were collected based on the surgical notes. Perioperative data included aorta cross clamping time, cardiopulmonary bypass time and the application of Lecompete maneuver.
Early postoperative complications are defined as delayed sternal closure, active bleeding after surgery, pulmonary artery stenosis, coronary artery re-transplantation, residual ventricular septal defect with significant shunt, atrioventricular block, extracorporeal membrane oxygenation support, cardiac arrest, necrotizing enterocolitis and diaphragmatic eventration. Hospital death was defined as death occurred before discharge.
Follow-up results included echocardiography, cardiac CTA, cardiac catheterization, and angiography. Echocardiographic assessment included color, continuous wave, and pulse wave Doppler date for all valves. Peak pressure gradient of 20mmHg was considered to be stenotic for neoaortic and pulmonary valve. Redo-procedure was defined as any kind of cardiovascular intervention after the ASO procedure including surgery or catheter-based procedure. The indication for reintervention of pulmonary or suprapulmonary stenosis was peak pressure gradient over 40mmHg. Pressure gradient across the LVOT or aortic valve over 50 mmHg was the indication for reintervention. Late death was defined as death occurred during follow up.
Relationships between preoperative and perioperative factors and hospital mortality were evaluated.
- Conditions
- Transposition of Great Vessels, Outcome, Fatal
- Being tested
- The arterial switch operation
- Keywords
- arterial switch operation, late referral, transposition of the great arteries
- Medical subject headings
- Transposition of Great Vessels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The arterial switch operationProcedure or surgery
The ASO is a procedure that emerged as an anatomically as well as physiologically appropriate solution to the transposition of the great arteries. The aorta and pulmonary artery are detached from their native roots and reattached to the opposite root; thus, the pulmonary root becomes the neo-aorta, and the aortic root becomes the neo-pulmonary artery.
The coronary arteries are transplanted from the aorta/neo-pulmonary artery to the pulmonary artery/neo-aorta.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | The only group in this retrospective study includes patients diagnosed with transposition of the great arteries receiving arterial switch operation in children's hospital of fudan university and shanghai children's medical center. Receives: Procedure: The arterial switch operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
death occurred within the hospital
Measured: within 1 month after ASO
late death
death occurred after discharge
Measured: after 1 month after ASO
redo operation
reintervention after the ASO procedure
Measured: through study completion, an average of 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Dec 2019
- Primary completion30 Mar 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transposition of Great VesselsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Bing Jia, MD, PhD, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089773
- Sponsor's protocol ID
- TGA-CTS
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transposition of the Great Arteries After Arterial Switch Operation: a Dual-center Study
- ClinicalTrials.gov ID
- NCT05089773
- Acronym / sponsor ID
- TGA-CTS
- Conditions
- Transposition of Great Vessels, Outcome, Fatal
- Keywords
- arterial switch operation, late referral, transposition of the great arteries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,281 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 22 Oct 2021 (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.
Transposition of the great arteries (TGA) is a complex cyanotic congenital heart disease and patients suffer from a high mortality rate within one year of age without appropriate management. The therapeutic effect of arterial switch operation (ASO) is satisfactory with low surgery mortality of 2-5%, and thus, has become the treatment of choice for surgical correction of d-TGA. Outcomes of ASO in TGA in china are rare. This is a retrospective study reporting the outcomes of ASO in TGA.
Detailed description
Transposition of the Great Arteries (TGA) is a relatively rare congenital heart disease and surgical treatment in China was developed in recent 20 years. The outcomes of arterial switch operation (ASO) in TGA in China have not been reported before. This study was designed to offer the experience of surgical treatment of TGA in two major pediatric heart centers affiliated in national children's medical center in China. In this retrospective study, a total of 1281 patients diagnosed with TGA received ASO treatment in Fudan Children's Hospital and Shanghai Children's Medical Center were recruited. Medical records and follow-up data of patients were complete. Patient characteristics and clinical data were obtained through review of the medical records, preoperative echocardiography and cardiac catheterization data, operative notes, and follow up reports. Description of the anatomy was confirmed on the preoperative echocardiogram, with clarification from the operative note as needed. Anatomy of the coronary arteries were collected based on the surgical notes. Perioperative data included aorta cross clamping time, cardiopulmonary bypass time and the application of Lecompete maneuver.
Early postoperative complications are defined as delayed sternal closure, active bleeding after surgery, pulmonary artery stenosis, coronary artery re-transplantation, residual ventricular septal defect with significant shunt, atrioventricular block, extracorporeal membrane oxygenation support, cardiac arrest, necrotizing enterocolitis and diaphragmatic eventration. Hospital death was defined as death occurred before discharge.
Follow-up results included echocardiography, cardiac CTA, cardiac catheterization, and angiography. Echocardiographic assessment included color, continuous wave, and pulse wave Doppler date for all valves. Peak pressure gradient of 20mmHg was considered to be stenotic for neoaortic and pulmonary valve. Redo-procedure was defined as any kind of cardiovascular intervention after the ASO procedure including surgery or catheter-based procedure. The indication for reintervention of pulmonary or suprapulmonary stenosis was peak pressure gradient over 40mmHg. Pressure gradient across the LVOT or aortic valve over 50 mmHg was the indication for reintervention. Late death was defined as death occurred during follow up.
Relationships between preoperative and perioperative factors and hospital mortality were evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Procedure: The arterial switch operationThe only group in this retrospective study includes patients diagnosed with transposition of the great arteries receiving arterial switch operation in children's hospital of fudan university and shanghai children's medical center. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020, regardless of the age, sex, and the anatomy.
Key inclusion criteria (1 listed)
- Patients diagnosed with the great arteries receiving the arterial switch operation in children's hospital of Fudan university and Shanghai children's medical center from January 2000 to March 2020.
Key exclusion criteria (1 listed)
- NA.
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 |
|---|---|---|
| The arterial switch operationThe ASO is a procedure that emerged as an anatomically as well as physiologically appropriate solution to the transposition of the great arteries. The aorta and pulmonary artery are detached from their native roots and reattached to the opposite root; thus, the pulmonary root becomes the neo-aorta, and the aortic root becomes the neo-pulmonary artery. The coronary arteries are transplanted from the aorta/neo-pulmonary artery to the pulmonary artery/neo-aorta. | Procedure or surgery | group 1 |
Primary outcome
hospital mortality
Time frame: within 1 month after ASO
death occurred within the hospital
late death
Time frame: after 1 month after ASO
death occurred after discharge
redo operation
Time frame: through study completion, an average of 10 year
reintervention after the ASO procedure
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 22 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Bing Jia, MD, PhD study chair
Children's Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transposition of Great Vessels and Outcome, Fatal, run by Children's Hospital of Fudan University at 2 sites 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 1 inclusion and 1 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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
hospital mortality (time frame: within 1 month after ASO). The study lists 3 primary outcomes in all. 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 22 Oct 2021.