Clinical trial NCT05515848: Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Official title: Regional, Multicentric Registry of Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Root Aneurysm
Aortic Regurgitation
Keywords: Valve-sparing aortic root replacement
David procedure
Acute aortic dissection
Aortic Regurgitation
Bicuspid aortic valve
French multicentric registry
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 529
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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) .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Conditional survival starting at 30 days
Secondary outcomes:
measure: Evaluate the overall cardiovascular survival results
timeFrame: up to 17 months
measure: 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)
timeFrame: up to 17 months
measure: Evaluate the risk of infective endocarditis
timeFrame: up to 17 months
measure: Evaluate the risk of stroke
timeFrame: up to 17 months
measure: Evaluate the risk of major bleeding event
timeFrame: up to 17 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Jean Christian ROUSSEL
role: PRINCIPAL_INVESTIGATOR
References: