Aortic Root AneurysmAORTLANTICNCT05515848
Aortic Valve-sparing Root Replacement, According to the Inclusion Technique Described by Tirone David
An observational study of Aortic Root Aneurysm and Aortic Regurgitation, run by Nantes University Hospital at 5 sites in France.
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]). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Root Aneurysm, Aortic Regurgitation
- How many people
- 529 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Nov 2021to 31 Jul 2023
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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) .
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU d'Angers
Angers
CHU de Brest
Brest
Nantes University Hospital
Nantes
CHU de Rennes
Rennes
CHU de Tours
Tours
About this study
Official title: Regional, Multicentric Registry of 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).
Read the 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
- Being tested
- No intervention
- Keywords
- Valve-sparing aortic root replacement, David procedure, Acute aortic dissection, Aortic Regurgitation, Bicuspid aortic valve, French multicentric registry
- Medical subject headings
- Aortic Root Aneurysm, Aortic Valve Insufficiency, Bicuspid Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this retrospective study.
| Study group | Role | What they receive |
|---|---|---|
| AORTLANTIC registry | 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)) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Conditional survival starting at 30 days
Secondary outcomes (5)
Evaluate the overall cardiovascular survival results
Number of patients alive
Measured: up to 17 months
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
Measured: up to 17 months
Evaluate the risk of infective endocarditis
Number of patients alive without aortic infective endocarditis
Measured: up to 17 months
Evaluate the risk of stroke
Number of patients alive without stroke
Measured: up to 17 months
Evaluate the risk of major bleeding event
Number of patients alive major bleeding event
Measured: up to 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start7 Nov 2021
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Root AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christian ROUSSEL, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515848
- Sponsor's protocol ID
- RC21_0540
- Acronym
- AORTLANTIC
- Status last verified
- Aug 2023
- First submitted
- 18 Aug 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No