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Completed

NCT Number: NCT05346497

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bentall

Procedure

Bentall procedure: include replacement of both aortic valve and root

David

Procedure

David procedure: include replacement of aortic root and aortic valvuloplasty

ARR

Procedure

Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.

Primary outcomes

  1. 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

Secondary outcomes

  1. Redo aortic surgery

    Time frame: From date of surgery until the date of redo aortic surgery for any reason, up to 20 years

    Patients underwent aortic surgery again for any reason

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start
2005
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2022
Registry last updated
Apr 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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