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The Heart
Valve Society

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)

Inclusion Criteria
The AVIATOR registry includes all patients with AR and/or ascending aorta aneurysms.
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.

Inform Consent
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)

Data Collection
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.
  • Patients characteristics
    Patient demography
    Cormobidity (Euroscore)
    Diagnosis of valve and/or ascending aorta disease
    Aorta phenotype
    Pre-operative medical imaging
  • Procedural data
    Peri-procedural data
    Per operative echographic data
    Echographic data at discharge
    Complications at discharge
  • Follow up data (every year after surgery)
    Clinical data
    Echographic data
    Complications since last follow-up

Download paper CRF (original version) (AVIATOR)
Download paper CRF (version without patient name) (AVIATOR)
Download data dictionary (AVIATOR)
Download paper CRF (original version) (HVS Aortic Valve database)
Download paper CRF (version without patient name) (HVS Aortic Valve database)
Download data dictionary (HVS Aortic Valve database)

Data safety
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?

"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":

Download Security and Patient Privacy Handling of the Telemedicine (database provider)
Download CleanWeb FDA 21 CFR part 11 Compliance analysis

Data entry
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