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

Completed

• Conditions: Aortic Root Aneurysm; Aortic Regurgitation
• Interventions: Other: No intervention

• Registration Number: NCT05515848
• Lead Sponsor: Nantes University Hospital

Brief Summary

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).

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 Timeline

• Study Start: 2021-11-07
• Study First Submitted: 2022-08-18
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 529

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AORTLANTIC registry	No intervention	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))

Primary Outcome Measures

Name	Time	Method
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	Conditional survival starting at 30 days	Number of patients alive without re-intervention for aortic valve dysfunction (surgery or TAVI)

Secondary Outcome Measures

Name	Time	Method
Evaluate the overall cardiovascular survival results	up to 17 months	Number of patients alive
Evaluate the risk of infective endocarditis	up to 17 months	Number of patients alive without aortic infective endocarditis
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)	up to 17 months	Number of patients alive without aortic insufficiency of grade equal to or greater than two
Evaluate the risk of stroke	up to 17 months	Number of patients alive without stroke
Evaluate the risk of major bleeding event	up to 17 months	Number of patients alive major bleeding event

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France