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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

529 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-07

Study Completion Date

2023-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transfemoral Transcatheter Aortic Valve Implementation at Hospital Without On-site Cardiac Surgery: Early Clinical Outcome in Patients With Prohibitive Surgical Risk.

NCT05886517

Aortic Stenosis

RECRUITING NA

Ischemic And Bleeding Risk Assessment After TAVR

NCT06000943

Aortic Valve Stenosis Transcatheter Aortic Valve Replacement

UNKNOWN

SAfe and Fast Discharge With Acurate Valve in Low Risk tavI Patients

NCT05983458

Stenoses, Aortic

RECRUITING NA

Transcatheter Aortic Valve Implantation Versus Standard Surgical Aortic Valve Replacement

NCT05261204

Prosthesis Survival Prosthesis; Cardiac, Heart, Functional Disturbance as Result

ENROLLING_BY_INVITATION

Transcatheter Aortic Valve Replacement for Pure Severe Aortic Valve Regurgitation

NCT06381271

Aortic Valve Regurgitation

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Root Aneurysm Aortic Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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))

No intervention

Intervention Type OTHER

There is no intervention in this retrospective study.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

There is no intervention in this retrospective study.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No