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

April 25, 2022 updated by: Shanghai Zhongshan Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Bentall
Patients who underwent Bentall procedure for ATAAD
Procedure: Bentall
Bentall procedure: include replacement of both aortic valve and root
David
Patients who underwent David procedure for ATAAD
Procedure: David
David procedure: include replacement of aortic root and aortic valvuloplasty
ARR
Patients who underwent aortic root reconstruction procedure except Bentall and David procedure for ATAAD
Procedure: ARR
Aortic root reconstruction: reconstruction instead of replacement of aortic root, without surgery of the valve. include sandwich procedure, adventitia invertion procedure, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of surgery until the date of death for any reason, up to 20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of surgery until the date of redo aortic surgery for any reason, up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2005

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2021-776R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type A Aortic Dissection

Clinical Trials on Bentall

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe