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NCT Number: NCT05515848

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention

Other

There is no intervention in this retrospective study.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Evaluate the overall cardiovascular survival results

    Time frame: up to 17 months

    Number of patients alive

  2. 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

  3. Evaluate the risk of infective endocarditis

    Time frame: up to 17 months

    Number of patients alive without aortic infective endocarditis

  4. Evaluate the risk of stroke

    Time frame: up to 17 months

    Number of patients alive without stroke

  5. Evaluate the risk of major bleeding event

    Time frame: up to 17 months

    Number of patients alive major bleeding event

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: AORTLANTIC

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 25, 2022
Registry last updated
Aug 14, 2023

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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