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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05346497
Other study ID # B2021-776R
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2005
Est. completion date November 1, 2021

Study information

Verified date April 2022
Source Shanghai Zhongshan Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1600
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bentall
Bentall procedure: include replacement of both aortic valve and root
David
David procedure: include replacement of aortic root and aortic valvuloplasty
ARR
Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Death for any reason Death for any reason From date of surgery until the date of death for any reason, up to 20 years
Secondary Redo aortic surgery Patients underwent aortic surgery again for any reason From date of surgery until the date of redo aortic surgery for any reason, up to 20 years
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