Press Release

Thursday, 31 March 2016

3rd ARISE Steering Committee Meeting / Study start at second clinical centre upcoming

Members of the ARISE Steering Committee met in Venice on the 18th and 19th of March 2016 and discussed progress within the ARISE project, which focuses on decellularized homografts for aortic valve replacement.

 

Within the first year of the project important steps such as study valve approval were achieved. The first patient was included to the prospective clinical trial in September 2015 (M9) well ahead of the planned Project Phase 3 – Clinical Study (M15 – 45).

 

So far, 7 young patients (mean age 10.0 ▒ 8.0 yrs.) have been included to the study, 4 further patients are awaiting surgery in April. The university hospital in Barcelona (IDIBAPS) will be the second of 6 clinical centres to start the clinical trial at their institution.

 

The Steering Committee Members developed the plan for Year 2 of the project.            Focus of the next 12 months will be on the timely start of the trial at all participating hospitals (Hannover-Prof. Haverich, Barcelona-Prof. Pomar, Leuven-Prof. Meyns, Leiden-Prof. Hazekamp, London-Prof. Pepper and Padua-Prof. Stellin).

 

The second focus was set on the continued collaboration with European Tissue Banks as the technique of decellularization relies on donated human heart valves. Dr. Adolfo Paolin of the local Tissue Bank Treviso joined the Steering Committee Meeting as invited guest.

Work on human biological material raises specific ethical issues and the ARISE consortium will ensure the highest standard of consent for the procurement of the valves. In this context, Prof. Hoppe from the Leibniz University of Hannover reported on the liaison with the independent Ethics and Governance Council (EGC) in the past 12 months and presented the leading items of the Ethics and Governance Framework as established in collaboration with the EGC.

 

The ARISE consortium will put even more emphasis on patient information about the option of aortic valve replacement using decellularized homografts and to this end all recent publications have been made Open Access and will be available in several languages on the project website.

 

The next meeting of the Steering Committee will be held during the 2016 Annual Meeting of the European Association of Cardiothoracic Surgeons (EACTS) in Barcelona.