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

Aortic Regurgitation Clinical Trial

— AORTLANTIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05515848
• Other study ID #: RC21_0540
• Status: Completed
• Start date: November 7, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 529
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Regurgitation
• Aortic Root Aneurysm
• Aortic Valve Insufficiency

Intervention

Other:
• No intervention
There is no intervention in this retrospective study.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients alive without re-intervention for aortic valve dysfunction (surgery or TAVI)	Conditional survival starting at 30 days
Secondary	Evaluate the overall cardiovascular survival results	Number of patients alive	up to 17 months
Secondary	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)	Number of patients alive without aortic insufficiency of grade equal to or greater than two	up to 17 months
Secondary	Evaluate the risk of infective endocarditis	Number of patients alive without aortic infective endocarditis	up to 17 months
Secondary	Evaluate the risk of stroke	Number of patients alive without stroke	up to 17 months
Secondary	Evaluate the risk of major bleeding event	Number of patients alive major bleeding event	up to 17 months