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Surgical Management of the Aortic Root and Long-term Outcomes For Acute Type A Aortic Dissection

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Fudan University

Status

Completed

Conditions

Type A Aortic Dissection

Treatments

Procedure: ARR
Procedure: David
Procedure: Bentall

Study type

Observational

Funder types

Other

Identifiers

NCT05346497
B2021-776R

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,600 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

1,600 participants in 3 patient groups

Bentall
Description:
Patients who underwent Bentall procedure for ATAAD
Treatment:
Procedure: Bentall
David
Description:
Patients who underwent David procedure for ATAAD
Treatment:
Procedure: David
ARR
Description:
Patients who underwent aortic root reconstruction procedure except Bentall and David procedure for ATAAD
Treatment:
Procedure: ARR

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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