Press Release

Tuesday, 20 December 2016

Presentation at the STS/AATS Tech-Con on Saturday 21, 2017 in Houston, Texas about the ARISE study

The ARISE study will be presented at the Society of Thoracic Surgeons 53rd annual meeting during the STS/AATS Tech-Con on Saturday 21st in Houston, Texas (10:15-12:00 pm Adult Cardiac Track/Endovascular. Moderators: Michael Borger, NY and Ali Khoynezhad, LA). Please find the abstract of the presentation below:

Surgical options are limited once aortic valve repair in young patients has failed or just is not feasible. The Ross operation as one option is a complex operation and sometimes creates a two-valve-problem. Decellularized fresh aortic homografts (DAH), which are processed directly after procurement and which are not cryopreserved or radiated, may constitute an alternative for aortic valve replacement as initial DAH results are encouraging.

Tudorache I, Horke A, Cebotari S, Sarikouch S, Boethig D, Breymann T, Beerbaum P, Bertram H, Westhoff-Bleck M, Theodoridis K, Bobylev D, Cheptanaru E, Ciubotaru A, Haverich A. Decellularized aortic homografts for aortic valve and aorta ascendens replacement. Eur J Cardiothorac Surg. 2016 Jul;50(1):89-97.

Within a European Commission funded prospective clinical trial six leading European centres for aortic root surgery do participate following the market approval of ARISE AV, which was issued by the Paul-Ehrlich Institute in Germany in July 2015 (

Prof. Mark Hazekamp, Leids Universitair Medisch Centrum – The Netherlands; Prof. John Pepper, Royal Brompton & Harefield – United Kingdom; Prof. Bart Meyns, Universitair Ziekenhuis Leuven – Belgium; Prof. Giovanni Stellin, Azienda Ospedaliera Universita Padova /Universita Degli Studi di Padova – Italy,  Prof. Jose Luis Pomar, l’Institut d’Investigacions Biomèdiques August Pi i Sunyer, Barcelona- Spain and Prof. Axel Haverich, Hannover Medical School-Germany

The clinical trial was started in September 2015 and aims to include 120 patients. In 12 months 32 patients were operated within the trial, with 4 further operations scheduled. The inclusion period is lasting until summer 2018, which should allow for reaching the calculated sample size. A 10-year follow up of the patients is planned.

More information about the ARISE project can be found on the website The study is listed with #NCT02527629 and was awarded with the “ENCePP Study Seal” (EUPAS10201).


Conflict of interests:

The decellularisation technique was developed and patented by A. Haverich and co-workers at Hannover Medical School. Axel Haverich holds shares in corlife oHG, a company for the processing of decellularized allografts used in this study.

The ARISE trial receives funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 643597.

ARISE AV is not approved by the FDA.