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

NCT05515848 | Completed

• 1 other identifier: RC21_0540
• Study Type: observational
• Target: 529
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Evaluate the overall cardiovascular survival results

  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)

  up to 17 months

• Evaluate the risk of infective endocarditis

  up to 17 months

• Evaluate the risk of stroke

  up to 17 months

• Evaluate the risk of major bleeding event

  up to 17 months

Study Arms (1)

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))

Other: No intervention

Interventions

No intervention OTHER

There is no intervention in this retrospective study.

AORTLANTIC registry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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) .

You may qualify if:

• Prosthetic replacement of the aortic valve intraoperatively during the first operation.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Aortic Root Aneurysm; Aortic Valve Insufficiency; Bicuspid Aortic Valve Disease

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean Christian ROUSSEL

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 25, 2022
• Study Start: November 7, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)