Total Anomalous Pulmonary Venous ConnectionNCT04234711
Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection
An observational study of Total Anomalous Pulmonary Venous Connection, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Total Anomalous Pulmonary Venous Connection
- What is being tested?
- Surgical strategy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2020to 1 Feb 2022
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Neonates and infants undergoing initial operation for total anomalous pulmonary venous connection in the participating hospitals of this study.
Who may be able to join
- Infants and neonates who are diagnosed with TAPVC
- Infants and neonates who undergo initial surgical repair for TAPVC.
Who cannot join
- Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries.
- Older than 1-year-old.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 520000
Xiaobing Liu, M.D., Ph. D, 15989201782, liuxb21@aliyun.com
About this study
Official title: Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers
The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.
Read the detailed description
An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform.
Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.
- Being tested
- Surgical strategy
- Keywords
- TAPVC, Surgical strategy, PVO, outcomes
- Medical subject headings
- Scimitar Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical strategyProcedure or surgery
To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgical group | Patients with total pulmonary venous connection undergo conventional surgical repair Receives: Procedure: Surgical strategy | |
| Sutureless surgical group | Patients with total pulmonary venous connection undergo sutureless surgical repair Receives: Procedure: Surgical strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of postoperative pulmonary venous obstruction (PVO)
in anastomosis or arborizations of pulmonary veins
Measured: 2 years
Mortality rate
all causes and surgical repair related
Measured: 2 years
Secondary outcomes (4)
The scores of postoperative quality of life: rating scale
Fill the rating scale through telephone or other communication
Measured: 2 years
Change in resting oxygen saturation
Answer question through telephone or other communication
Measured: 2 years
Value of tricuspid annular plane systolic excursion
Measured by echocardiology from follow-up
Measured: 2 years
Development of all kinds of arrhythmia
Measured by electrocardiography
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start20 Feb 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Anomalous Pulmonary Venous ConnectionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhuang, M.D., Ph D., Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234711
- Sponsor's protocol ID
- 20190505
- Status last verified
- Jan 2020
- First submitted
- 12 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sutureless Technique and Conventional Repairs for Total Anomalous Pulmonary Venous Connection: an Observational Study by Chinese Heart Centers
- ClinicalTrials.gov ID
- NCT04234711
- Acronym / sponsor ID
- 20190505
- Keywords
- TAPVC, Surgical strategy, PVO, outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 21 Jan 2020 (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.
The purpose of this study is to evaluate the efficacy of conventional repair and sutureless surgical repair of total anomalous pulmonary venous connection.
Detailed description
An observational, non-randomized multi-center study is proposed to compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection. Subjects will be enrolled at Guangdong Provincial People's Hospital (GPPH) and three to five participating hospitals. All clinical interventions will follow the participating hospital's standard of care. Informed consent will be obtained from all study participants before study enrollment. After undergoing their surgical repairs, study participants will be followed up at 1, 3, 6 and 12 months after initial surgery and annually thereafter. All preoperative and postoperative medical records data will be submitted to a centralized database at GPPH through a secure online research platform.
Baseline and post-operative (6 months) assessments will include a history and physical examination, a quality of life survey, physical examinations, liver and kidney function assessments, serum brain natriuretic peptide (BNP), echocardiography and electrocardiography. Besides, a small amount of common pulmonary vein tissue may be required for hematein and eosin staining.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional surgical group | – | Procedure: Surgical strategyPatients with total pulmonary venous connection undergo conventional surgical repair |
| Sutureless surgical group | – | Procedure: Surgical strategyPatients with total pulmonary venous connection undergo sutureless surgical repair |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates and infants undergoing initial operation for total anomalous pulmonary venous connection in the participating hospitals of this study.
Key inclusion criteria (2 listed)
- Infants and neonates who are diagnosed with TAPVC
- Infants and neonates who undergo initial surgical repair for TAPVC.
Key exclusion criteria (2 listed)
- Concommitant diagnoses including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia, or transposition of the great arteries.
- Older than 1-year-old.
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 |
|---|---|---|
| Surgical strategyTo compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection | Procedure or surgery | Conventional surgical group, Sutureless surgical group |
Primary outcome
Incidence rate of postoperative pulmonary venous obstruction (PVO)
Time frame: 2 years
in anastomosis or arborizations of pulmonary veins
Mortality rate
Time frame: 2 years
all causes and surgical repair related
4 secondary outcomes
The scores of postoperative quality of life: rating scale
Time frame: 2 years
Change in resting oxygen saturation
Time frame: 2 years
Value of tricuspid annular plane systolic excursion
Time frame: 2 years
Development of all kinds of arrhythmia
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- 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.
Jian Zhuang, M.D., Ph D. study director
Guangdong Provincial People's Hospital
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 Total Anomalous Pulmonary Venous Connection, run by Guangdong Provincial People's Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Liufu, M.D. (020-83827812, liufurong103@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of postoperative pulmonary venous obstruction (PVO) (time frame: 2 years). The study lists 2 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 11 Feb 2020.