TAVI Frequently Asked Questions
How was the database developed?
The database developed by the ACOR TAVI Registry Steering Committee is based on the US registry, TVT, and adapted for local conditions. Feedback on the data being collected is welcome but at this stage there has been an initial finalisation to allow data collection and entry to proceed.
Who owns the data and how will the generated data be used?
The Client Services Agreement (CSA) details that, subject to clause 6.2(a), the Client (the hospital) retains all Intellectual Property Rights in the data submitted to the Registry. It further states that the Client grants to ACOR an irrevocable, nonexclusive, worldwide, perpetual, royalty free licence to use, reproduce, publish, communicate and adapt the data submitted to the Registry in accordance with the CSA for its purposes including to incorporate the data in ACOR’s reports and to aggregate that data with other data.
Individual clinicians may access aggregated de-identified data and data relating to themselves.
Hospitals (the Client) may only access their own data and aggregated de-identified data.
Patients have the right to request their data be removed from the Registry, corrected if there is an error or be provided with access to their data.
Publication of data
ACOR’s Research and Publications Committee oversees requests for publication and ensures fairness and equity.
What is the mechanism for data entry?
The ACOR TAVI database is hosted on REDCap and SAHMRI is working with each accredited hospital to facilitate the transfer of data. An excel spreadsheet is being developed to enable bulk data transfer.
How is the Registry funded and is there support available to hospitals to defray the cost of participating?
The TAVI registry does not have government funding. The TAVI Registry is a “user pays” registry and all funds are expended on the development, running and maintenance of the Registry.
The commencement phase of the build was achieved via a donation from industry. The final development, ongoing running and maintenance together with the costs of running the Steering Committee, Project Manager’s time and associated expenses are covered via a hospital registration fee which is paid annually. ACOR appreciates that a number of practitioners already contribute to their own internal databases. Our Registry provider, SAHMRI, is working with each accredited practitioner and their accredited hospital to ensure the smooth transfer of data to the ACOR Registry.
How was the TAVI Steering Committee formed?
- ACOR identified the need for a National TAVI Registry
- The CSANZ Interventional Council recommended experienced operators from all jurisdictions across Australia and New Zealand
- The ANZSCTS were involved in the early planning and represented on the Steering Committee by their President at that time, Prof Paul Bannon
- Acting Chair – Prof David Brieger;
- Nominations and election of Chair (Prof Darren Walters) and Deputy Chair (A/Prof Ajay Sinhal)
- Expressions of Interest called for two positions on the Committee. One for an senior accredited TAVI practitioner and one for a practitioner who is within 5 years of having commenced TAVI practice
What is the term of office of the TAVI Steering Committee?
The term of office is 3 years with the option of a second three year term. No member may serve for more than 6 consecutive years, however a member may serve in different positions on the Committee for a period exceeding 6 consecutive years.