Type A Aortic DissectionNCT05346497
Surgical Management of the Aortic Root and Long-term Outcomes For Acute Type A Aortic Dissection
An observational study of Type A Aortic Dissection, run by Shanghai Zhongshan Hospital.
Trial summary
The investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type A Aortic Dissection
- What is being tested?
- Bentall, David and ARR
- Type of treatment
- Surgery or procedure
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Based on currently available data on aortic-related procedures in our department from 2005 to 2021, we expect to include 1600 patients at the end of the study.
Who may be able to join
- Patients who were followed up at our hospital for aortic lesions or who underwent aortic root surgery (including the Bentall procedure, the David procedure, and other aortic root angioplasty or replacement procedures)
- Patients older than 18 years of age, no specific gender requirement
- Patients who are compliant and able to complete follow-up
- Patients who understand the purpose of the study, voluntarily participate, and have signed the Biospecimen and Health-Related Information Donation Form by themselves or their legal representative.
- Patients who understand the purpose of the study, voluntarily participate and have signed the informed consent form for donation of biological samples and health-related information by themselves or their legal representative
Who cannot join
- Patients who are unable or unwilling to participate in the study and sign the informed consent form
- Patients with poor compliance and unable to complete follow-up
- Patients with severe organ insufficiency
About this study
The investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Clinical data including age, gender, comorbidities, surgical informations and perioperative informations will be collected. All patients will receive follow-ups in hospital or by telephone.
All the informations will be analyzed by SPSS to show the difference of both perioperative and long-term results among different surgical strategies.
Read the detailed description
Acute type A aortic dissection (ATAAD) is a rare but life threatening situation requiring immediate intervention. Regarding emergency operation for ATAAD, an important principle is to reconstruct the afflicted aorta to prevent fatal rupture.
For aortic root dissection, the Bentall procedure has been the standard operation and has been proven simple and effective. However, the requirement for lifelong anticoagulation therapy is associated with increased risk of thromboembolic and bleeding complications. Valve sparing aortic root reimplantation (David reimplantation), which has been proven effective in root aneurysm with satisfactory safety and long-term outcomes, is an appealing alternative to preserve native aortic valve, especially for younger patients with intact valve function. Aortic root reconstruction without valve surgery is also a well-used strategy for aortic root dissection, but the long-term outcome is still controversial.
The investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Clinical data including age, gender, comorbidities, surgical informations and perioperative informations will be collected. All patients will receive follow-ups in hospital or by telephone.
All the informations will be analyzed by SPSS to show the difference of both perioperative and long-term results among different surgical strategies.
- Conditions
- Type A Aortic Dissection
- Being tested
- Bentall, David, ARR
- Keywords
- Type A Aortic Dissection, Aortic Root Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BentallProcedure or surgery
Bentall procedure: include replacement of both aortic valve and root
DavidProcedure or surgery
David procedure: include replacement of aortic root and aortic valvuloplasty
ARRProcedure or surgery
Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.
| Study group | Role | What they receive |
|---|---|---|
| Bentall | Patients who underwent Bentall procedure for ATAAD Receives: Procedure: Bentall | |
| David | Patients who underwent David procedure for ATAAD Receives: Procedure: David | |
| ARR | Patients who underwent aortic root reconstruction procedure except Bentall and David procedure for ATAAD Receives: Procedure: ARR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death for any reason
Death for any reason
Measured: From date of surgery until the date of death for any reason, up to 20 years
Secondary outcomes (1)
Redo aortic surgery
Patients underwent aortic surgery again for any reason
Measured: From date of surgery until the date of redo aortic surgery for any reason, up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start1 Jan 2005
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type A Aortic DissectionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05346497
- Sponsor's protocol ID
- B2021-776R
- Status last verified
- Apr 2022
- First submitted
- 21 Jan 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of the Aortic Root and Long-term Outcomes For Acute Type A Aortic Dissection
- ClinicalTrials.gov ID
- NCT05346497
- Acronym / sponsor ID
- B2021-776R
- Conditions
- Type A Aortic Dissection
- Keywords
- Type A Aortic Dissection, Aortic Root Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 26 Apr 2022 (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 investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Clinical data including age, gender, comorbidities, surgical informations and perioperative informations will be collected. All patients will receive follow-ups in hospital or by telephone.
All the informations will be analyzed by SPSS to show the difference of both perioperative and long-term results among different surgical strategies.
Detailed description
Acute type A aortic dissection (ATAAD) is a rare but life threatening situation requiring immediate intervention. Regarding emergency operation for ATAAD, an important principle is to reconstruct the afflicted aorta to prevent fatal rupture.
For aortic root dissection, the Bentall procedure has been the standard operation and has been proven simple and effective. However, the requirement for lifelong anticoagulation therapy is associated with increased risk of thromboembolic and bleeding complications. Valve sparing aortic root reimplantation (David reimplantation), which has been proven effective in root aneurysm with satisfactory safety and long-term outcomes, is an appealing alternative to preserve native aortic valve, especially for younger patients with intact valve function. Aortic root reconstruction without valve surgery is also a well-used strategy for aortic root dissection, but the long-term outcome is still controversial.
The investigators focus on the patients who underwent aortic root surgery for acute type A aortic dissection between 2005.01-2021.11. The patients are divided into 3 groups according to the different aortic root surgical methods(Bentall，David and root reconstruction). Clinical data including age, gender, comorbidities, surgical informations and perioperative informations will be collected. All patients will receive follow-ups in hospital or by telephone.
All the informations will be analyzed by SPSS to show the difference of both perioperative and long-term results among different surgical strategies.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bentall | – | Procedure: BentallPatients who underwent Bentall procedure for ATAAD |
| David | – | Procedure: DavidPatients who underwent David procedure for ATAAD |
| ARR | – | Procedure: ARRPatients who underwent aortic root reconstruction procedure except Bentall and David procedure for ATAAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Based on currently available data on aortic-related procedures in our department from 2005 to 2021, we expect to include 1600 patients at the end of the study.
Key inclusion criteria (5 listed)
- Patients who were followed up at our hospital for aortic lesions or who underwent aortic root surgery (including the Bentall procedure, the David procedure, and other aortic root angioplasty or replacement procedures)
- Patients older than 18 years of age, no specific gender requirement
- Patients who are compliant and able to complete follow-up
- Patients who understand the purpose of the study, voluntarily participate, and have signed the Biospecimen and Health-Related Information Donation Form by themselves or their legal representative.
- Patients who understand the purpose of the study, voluntarily participate and have signed the informed consent form for donation of biological samples and health-related information by themselves or their legal representative
Key exclusion criteria (3 listed)
- Patients who are unable or unwilling to participate in the study and sign the informed consent form
- Patients with poor compliance and unable to complete follow-up
- Patients with severe organ insufficiency
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 |
|---|---|---|
| BentallBentall procedure: include replacement of both aortic valve and root | Procedure or surgery | Bentall |
| DavidDavid procedure: include replacement of aortic root and aortic valvuloplasty | Procedure or surgery | David |
| ARRAortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc. | Procedure or surgery | ARR |
Primary outcome
Death for any reason
Time frame: From date of surgery until the date of death for any reason, up to 20 years
Death for any reason
1 secondary outcome
Redo aortic surgery
Time frame: From date of surgery until the date of redo aortic surgery for any reason, up to 20 years
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 26 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type A Aortic Dissection, run by Shanghai Zhongshan Hospital.
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 5 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 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Death for any reason (time frame: From date of surgery until the date of death for any reason, up to 20 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 26 Apr 2022.