NCT05515848

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 529 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Root Aneurysm
• Aortic Regurgitation

Interventions

Type	Name	Description
OTHER	No intervention	There is no intervention in this retrospective study.

Timeline

• Start date: 2021-11-07
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2022-08-25
• Last updated: 2023-08-14

Locations

1 site across 1 country: France