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

NCT05346497 | Completed

• 1 other identifier: B2021-776R
• Study Type: observational
• Target: 1,600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type A Aortic Dissection

Keywords

Type A Aortic Dissection; Aortic Root Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Redo aortic surgery

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

Study Arms (3)

Bentall

Patients who underwent Bentall procedure for ATAAD

Procedure: Bentall

David

Patients who underwent David procedure for ATAAD

Procedure: David

ARR

Patients who underwent aortic root reconstruction procedure except Bentall and David procedure for ATAAD

Procedure: ARR

Interventions

Bentall PROCEDURE

Bentall procedure: include replacement of both aortic valve and root

Bentall

David PROCEDURE

David procedure: include replacement of aortic root and aortic valvuloplasty

David

ARR PROCEDURE

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

ARR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Interventions

Red Cross

Intervention Hierarchy (Ancestors)

International Agencies; Organizations; Health Care Economics and Organizations; Voluntary Health Agencies; Organizations, Nonprofit

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: April 26, 2022
• Study Start: January 1, 2005
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04