Work plan / phases


The central aim of the ARISE project is to transfer an innovative development in regenerative medicine, the DAH, to the clinic by evaluating the safety and feasibility in a clinical study.


Project Phase 1

Establishment of Management and Oversight Structures (M1 – 9)

Phase 1 of the project will focus on the establishment of robust structures to underpin effective project and quality management, decision-making, and accountability throughout the duration of the project and beyond. This will include the convening of the Steering Committee and the external advisory boards (Data Safety and Monitoring Board (DSMB) and the Ethics and Governance Council (EGC)) to monitor and advise project activities. Furthermore, a roadmap for the effective dissemination and use of knowledge generated in the project will be established to ensure maximum impact in all phases.


Project Phase 2

Study Preparation (M 1 – 15)

Phase 2 concentrates on the preparatory measures necessary for the initiation of the clinical study. This includes dialogue with the competent regulatory authorities towards the application for approval of the study valve. It also involves internal contract preparation for study contracts with the clinical partners and quality assurance agreements with their local supporting tissue banks for the supply of homografts.


Project Phase 3

Clinical Study (M15 – 45)

Phase 3 involves all aspects involved in the implementation of the clinical study. A prospective multi-centre clinical study at 6 leading cardiothoracic surgery centres will be performed to evaluate the safety and efficacy of DAH for AVR. This also includes the procurement and processing of homografts to be implanted during the study life-time. Based on the number of AVR carried out in these institutions every year, the proposed recruitment of 20 patients from each of these clinical centres within 18 months is realistic. Furthermore, it is anticipated that patient demand will rise with increased awareness of the project, as there already is a large waiting list at MHH (Partner 1) for potential decellularised homograft recipients. The calculated cohort size of 120 patients (100 after drop-outs) will allow for a thorough evaluation of re-intervention rates, hemodynamic performance and safety of DAH for AVR in aortic valve disease. Data oversight will be undertaken by the independent DSMB. In addition, the study will be closely accompanied and advised by the external EGC in all relevant ethical, legal and social aspects.


Project Phase 4

Analysis, Follow-Up and Sustainability Measures (M46 – 51)

Statistical analysis in direct comparison to current valve substitutes will allow for exact scientific evaluation of the safety and efficacy of DAH. Results will be published and disseminated to the scientific community, patient organisations and political stakeholders. Furthermore, measures to support follow-up beyond the ARISE project in the form of a specialised ARISE registry will be implemented to assess long-term results and make project data available for further clinical and research use. Established structures for homograft procurement with the local supporting tissue banks will be used for the further exploitation of the developed method of decellularisation. Strategic partnerships may be used for technology transfer to consortium partners and other institutions in the EU.