Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David (AORTLANTIC)

August 9, 2023 updated by: Nantes University Hospital

Regional, Multicentric Registry of Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David

Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at six centers (Nantes - Rennes - Brest - Angers - Tours [two centers]). The main objective of this study is to evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective observational study of all patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David.

Inclusion criteria: Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2020, at one of the six centers: Nantes, Rennes, Brest, Angers, Tours (two centers).

Non-inclusion criteria: Prosthetic replacement of the aortic valve intraoperatively during the first operation.

Objectives and endpoints :

  • The survival without re-intervention for aortic valve dysfunction (surgery or TAVI)
  • The overall cardiovascular survival
  • The survival without aortic insufficiency of grade equal to or greater than two
  • The survival without aortic infective endocarditis
  • Assessment of long-term stroke risk Assessment of the risk of a major bleeding event in the long term Data analysis : The AORTLANTIC study is included in the EPICARD registry which is the official, national database of the French Society of Cardiac Surgery. Study data will then be collected using EPICARD's electronic Case Report Form (eCRF) and then analyzed using a multivariate Cox model. For the follow-up, the WEPI eCRF is used.

Study Type

Observational

Enrollment (Actual)

529

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at five centers (Nantes, Rennes, Brest, Angers,Tours UH) .

Description

Inclusion Criteria:

  • Patients undergoing aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at one of the six centers: Nantes, Rennes, Brest, Angers,Tours UH.

Non inclusion criteria :

  • Prosthetic replacement of the aortic valve intraoperatively during the first operation.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AORTLANTIC registry
Patients undergoing aortic root surgery with aortic valve conservation, using the inclusion technique described by Tirone David, between January 1, 2004 and December 31, 2021, at five centers (Nantes - Rennes - Brest - Angers - Tours University Hospital (UH))
Other: No intervention
There is no intervention in this retrospective study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the survival without re-intervention for aortic valve dysfunction (surgery or TAVI), after aortic root surgery with conservation of the aortic valve, according to the inclusion technique described by Tirone David
Time Frame: Conditional survival starting at 30 days
Number of patients alive without re-intervention for aortic valve dysfunction (surgery or TAVI)
Conditional survival starting at 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the overall cardiovascular survival results
Time Frame: up to 17 months
Number of patients alive
up to 17 months
Evaluate the absence of aortic insufficiency greater than or equal to grade two between the two types of aortic tube graft (right prosthesis or Valsalva prosthesis)
Time Frame: up to 17 months
Number of patients alive without aortic insufficiency of grade equal to or greater than two
up to 17 months
Evaluate the risk of infective endocarditis
Time Frame: up to 17 months
Number of patients alive without aortic infective endocarditis
up to 17 months
Evaluate the risk of stroke
Time Frame: up to 17 months
Number of patients alive without stroke
up to 17 months
Evaluate the risk of major bleeding event
Time Frame: up to 17 months
Number of patients alive major bleeding event
up to 17 months

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Jean Christian ROUSSEL, Nantes University 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)

November 7, 2021

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

August 18, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC21_0540

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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