Data Safety Monitoring Board

An external Data Safety Monitoring Board (DSMB) will be established to continuously monitor and protect patient safety throughout the clinical study with an emphasis on progress, safety data and critical efficacy endpoints of the clinical study. The Clinical Study Director will closely collaborate with the DSMB throughout the study period and the DSMB will be integrated in the set-up up of the clinical trial including the implementation of the study database. DSMB meetings may be requested by the sponsor, the Coordinator, the EU Project Officer, EGC members or institutional review boards at any time to discuss any safety concerns. The Board will conduct remote reviews throughout the project lifetime and will be invited to participate in SC meetings. All life-threatening severe adverse events (SAE) will be reported immediately to the DSMB in addition to regulatory requirements. In the case of accumulation of severe unexpected adverse events (SUSAR), the DSMB will convene in an extraordinary meeting to advise the sponsor on the continuation, modification, or termination of the study.


The following experts have agreed to join the ARISE DSMB:

Prof. Siegfried Kropf, University of Magdeburg (DE), is head of the Institute for Biometry and Medical Informatics and avails of extensive experience in multi-centre trials in congenital heart disease with special interest in parametrical and nonparametrical statistical analysis of clinical studies. He also has been involved in Data Safety Monitoring Boards for numerous clinical studies funded by the German Science Foundation and for the German Competence Network for Congenital Heart Defects.

Prof. John Dark, Newcastle University (UK), is Professor of Cardiothoracic Surgery and Consultant Cardiothoracic Surgeon at Newcastle University and Freeman Hospital. He is a specialist for transplantation and member of numerous international working groups dealing with donation, transplantation and ethics. He is a past-President of the European Society for Organ Transplantation and of the International Society for Heart and Lung Transplantation, and serves on the Council of the British Transplantation Society.

Prof. Rune Haaverstad, Haukeland University of Bergen, Norway is head of the Department of Cardiothoracic Surgery and specialist for aortic surgery. He has been involved in numerous heart valve studies dealing with aortic valve replacement and repair and published extensively on aortic valve replacement.