Outcomes evaluation in cardiac surgery has a long tradition through national registries. However, none of them allow detailed pathology driven analysis and long term follow-up is often lacking. The Heart Valve Society (HVS) aortic valve repair research network started the Aortic Valve Insufficiency and ascending aorta Aneurysm InternATiOnal Registry – the AVIATOR initiative – is aimed to improve outcomes for patients with aortic valve regurgitation and dystrophic aorta, to enhance uniform scientific reporting, to optimize multidisciplinary patient care and to assess quality of care from medical management to surgical outcomes.
|Download protocol (AVIATOR)||Download protocol (HVS Aortic Valve Database)|
The AVIATOR registry includes all patients with AR and/or ascending aorta aneurysms.
Patients with AR > grade 1 (mild AR) – inclusive congenital mixed aortic valve disease – and/or an aortic diameter = 40 mm are eligible for the medical registry. Patients who are operated on because of AR (including congenital mixed aortic valve disease) and/or aortic aneurysm (root or tubular ascending aorta) are eligible for the surgical database. Patient characteristics are leading and the performed intervention is secondary. This means that both patients who undergo AV repair including valve sparing root replacement as well as AV replacement – including composite valve graft replacement – are eligible. Centers without an AV repair program are encouraged to join the AVIATOR initiative as well. It is important to enroll all consecutive patients within a center, and not only the successful repairs. Isolated AV stenosis is excluded. Operative correction of an aneurysm of the ascending aorta can be either root and/or supra coronary aorta replacement. Patients operated for aortic dissection (Type A) are eligible as well.
Here you can find some template Inform Consent letters you could use and adjust to your local institutional setting.
| Download English version (AVIATOR)
Download French version (AVIATOR)
Download Dutch version (AVIATOR)
|Download English version (HVS Aortic Valve Database)|
The adult surgical database is open for patient enrollment since January 2013. Collected data includes: baseline patient characteristics, procedural information, in-hospital outcomes, longitudinal measurement of echo parameters and (valve related) events during at least yearly follow-up.
Handling Personal Patient Data (optional)
The name and first name of a patient, his home address, personal telephone number or email address are "Personal Patient Data" and can be stored in AVIATOR database.
How personal patient data can be useful?
- It provides 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.
- To empower the patient on his clinical Follow-up with phone application or dedicated web platform implementing directly the database.
"Personal Patient Data" are subject to special protection regulations.
CleanWEB is compliant with FDA (For additional information on this compliance, please refer to the following FDA 21 CFR Part 1 – Compliance analysis,) All activities related to development and provision of collaborative software for clinical research and epidemiology have been audited and are certified as complying with the requirements of standard ISO 9001:2008.
CleanWEB provides the necessary features to ensure the adequate management of "Personal Patient Data":
- In the database where they are persisted and stored, Personal Data are encrypted.
- This database is separate from the CRF database.
- The access rights management system of CleanWEB based on User Authentication with access codes, enables to fully control the access to the Patient Data and allow such access only to relevant personnel.
- Except if otherwise specifically required and documented by the Customer, such access is only granted to personnel of the investigational site where the patient is enrolled and CleanWEB provides all features to ensure this requirement.
- For other personnel such as CRA, Data Manager, Project Manager, Principal Investigator etc, the corresponding data fields may 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.
- Personal Patient Data cannot be included in the extraction files.
- CleanWEB provides features to fully delete such data if the patient so wishes.
Download CleanWeb FDA 21 CFR part 11 Compliance analysis
Data entry is possible directly online (patient by patient), but if a center has a good local database, it is possible to use the upload facility.
Download online (patient by patient) data entry manual
Download data-batch upload manual