- Under scientific responsibility of the Heart Valve Society
- Compliant with ICH/GCP
- Hosted by Telemedicine, Paris
- Each center remains the owner of its data and can upload retrospective patients from local data base
Three good reasons to participate
- A clinically orientated database where you can search each patient by his name (compliant with US and EU regulation for safety of personal data) and visualize directly patient medical summary with echo table online or printable as PDF form.
- Overview of your own results compared to complete database (friendly surgical report). Easy online patients selection of any variables. Online extraction of your own data.
- Initiating your own research (including extra variables specific to your center) and/or participate to multicenter analysis.
The AVIATOR initiative is a longitudinal observational cohort study enrolling patients with ascending aorta aneurysm and/or AR. Centers all over the world who are interested can participate.
The registry contains two separate entities:
- AVIATOR medical registry to evaluate the natural history of non-operated patients (evaluation of current guideline's criteria for operation);
- AVIATOR surgical registry to evaluate long term patient's outcomes after surgical treatment (AV repair or replacement).
The AVIATOR registry is designed to be of additive value for physicians. Beside data analysis and research it can be used as a clinical tool in daily practice as there is the possibility to generate a ‘Clinical Summary’ on patient level. Patients can be searched by their names to support the physician (see for further specification the data safety section). The ‘Clinical Summary’ summarizes all relevant information of that particular patient in one on-screen-view or report to be printed. This summary can be used by physicians in the outpatient clinic as it will visualize for example all echo results from pre- and post-op till the last follow-up visit. In addition, the application will allow to filter and select specific subgroups, like a list of the deceased patients, patients with AR grade 2 or patients that need to be contacted for follow-up.
Telemedicine technologies hosts the database application (CleanWebTM). Telemedicine technologies S.A.S is located at 102-104, avenue Edouard Vaillant, 92100 Boulogne-Billancourt.
Data are entered on a web-based Case Report Form (CRF) through a secure data-entry system. Telemedicine technologies hosts the database application (CleanWebTM) in Paris, France.21 The data system is set up according to Good Clinical practice (GCP) guidelines, is United States Food and Drug Administration (FDA) compliant (21 CFR part 11) and meets the criteria of European legislation (EU Directive 2001/20/EC/Directive 2005/28/EC, Annex 11, cGMP).
Patient Identifiable Data
CleanWEB offers the availability to enter Patient Identifiable Data like the last and first name of a patient for practical use in clinic. Each center can decide if it wishes to use this feature or not, and should inform their Institutional Review Board before enrolling patients. The patient name is subject to special protection regulations. It is the responsibility of the owner of the collected data to justify why such identifying data are needed. The online database CleanWEB is compliant with the most demanding requirements.
This includes the following:
- The Patient Identifiable Data is stored encrypted
- It is saved on a separate server than the medical parameters.
- Differentiation of access rights enables to fully control the access to the Patient Identifiable Data and allow such access only to relevant personnel (within the own site only).
- For other personnel (such as CRA, Data Manager, Project Manager, Principal Investigator) the corresponding data fields will be displayed in the user interface but their value will be set to *****. The term "User Interface" shall also include all dashboards and all printable material that may be generated using CleanWEB.
- Patient Identifiable Data cannot be included in the extraction files.20