Subaortic StenosisNCT06751368
The Fate of Aortic Valve After SAS Surgery in Children
An observational study of Subaortic Stenosis and Congenital Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Subaortic Stenosis, Congenital Heart Disease, Aortic Regurgitation
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2008to 30 Nov 2024
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients age from 0-18 underwent SAS surgical repair at Fuwai Hospital.
Who may be able to join
- Age from 0-18
- Clinical diagnosis of subaortic stenosis and underwent surgery
Who cannot join
- Diagnosed with hypertrophic cardiomyopathy
- Underwent concomitant previous surgical repair for aortic valve or SAS
- Follow-up time less than 1 year or lack of detailed information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aortic Valve Regurgitation After Surgical Repair for Subaortic Stenosis in Children
Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. This study aims to investigate the incidence and risk factors of SAR in SAS patients and evaluate the long-term postoperative outcomes.
- Medical subject headings
- Aortic Stenosis, Subvalvular, Heart Defects, Congenital, Aortic Valve Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Postoperative significant AR (SAR)
Measured: Through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2008
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subaortic StenosisStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Retrospective
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pan Xiangbin, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751368
- Sponsor's protocol ID
- 2022-1727
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve Regurgitation After Surgical Repair for Subaortic Stenosis in Children
- ClinicalTrials.gov ID
- NCT06751368
- Acronym / sponsor ID
- 2022-1727
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 27 Dec 2024 (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.
Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. This study aims to investigate the incidence and risk factors of SAR in SAS patients and evaluate the long-term postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients age from 0-18 underwent SAS surgical repair at Fuwai Hospital.
Key inclusion criteria (2 listed)
- Age from 0-18
- Clinical diagnosis of subaortic stenosis and underwent surgery
Key exclusion criteria (3 listed)
- Diagnosed with hypertrophic cardiomyopathy
- Underwent concomitant previous surgical repair for aortic valve or SAS
- Follow-up time less than 1 year or lack of detailed information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Postoperative significant AR (SAR)
Time frame: Through study completion, an average of 4 year
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 27 Dec 2024.
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 Subaortic Stenosis and Congenital Heart Disease, run by Chinese Academy of Medical Sciences, Fuwai 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 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 27 Dec 2024. 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?
Rate of Postoperative significant AR (SAR) (time frame: Through study completion, an average of 4 year). 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 27 Dec 2024.