Clinical Centre (in cooperation with Partner 7 AOP)

The University of Padua (UNIPD), founded in 1222, plays an important role in scholary and scientific research at both European and world level. UNIPD fosters and sustains an environment that facilitates the highest quality scholarship and research, providing leadership in setting research goals for the University, developing and implementing strategies for achieving research goals, capitalizing on the interdisciplinary strength of University research centres, and ensuring that the research infrastructure is robust and responsive to the expanding and ever-changing needs of researchers. Currently, UNIPD has 32 Departments, and 72 Research and Service Centres. The International Research Office offers a series of services to the University researchers involved in or applying for EU funded projects.

The Department of Cardiac, Thoracic and Vascular Sciences (DCTV) of UNIPD is a centre of excellence that brings together the human resources and experience of the University (Partner 6) and the University Hospital (Partner 7), by linking diagnosis and treatment to clinical, applied and basic research. The DCTV is one of the most research-active surgical units of the country with a long history in innovative cardiac surgery and heart transplantation, and is also one of the oldest medical institutions in Italy dealing with congenital heart malformations. The first human heart transplant in Italy was performed in Padua in 1985, followed by the first neonatal heart transplant in 1987. In addition, surgery for congenital heart disease has always been performed at the highest level, allowing for the first successful palliation for hypoplasic left heart syndrome in Europe in 1991. Clinical evaluation and follow-up of congenital heart diseases are routinely performed to assess long term results and continuously improved techniques.

DCTV as a centre of excellence treats patients with cardiovascular and thoracic diseases from across Italy. It also works in close collaboration with the Department of Women’s and Children’s Health of UNIPD in treating patients with congenital cardiac diseases. The Paediatric & Congenital Cardiovascular Surgery Unit of Padua ranks among the busiest centres for paediatric cardiovascular surgery and cardiology in the country, with over 300 surgical procedures per year, and with a high index of Complexity/Performance, as stated by the European Association for Cardio-Thoracic Surgery (EACTS) Database. Because of its reputation for excellence in patient care, research and leading technologies, a large number of patients throughout the country are sent to this Unit for treatment. The majority of congenital heart diseases are repaired within the first 3 months of life. Adults with congenital heart disease are treated for re-operation or primary repair.

This centre is also part of the Baby Heart Italian Group for excellence in quality in Paediatric Cardiac Surgery; the International Nomenclature Working Group which unifies a selected group of experts in congenital cardiac surgery in Europe and Northern America; the EACTS Congenital database and the World Society for Paediatric and Congenital Heart Disease.

Main tasks

UNIPD, in cooperation with Partner 7 AOP, will contribute as a joint clinical centre predominantly to WPs 3, 4 and 5 and will also be actively involved in WP 6 Dissemination and Outreach. The main tasks of the participant are:

• Homograft supply by local tissue banks: Draft Memoranda of Understanding and preparation of reimbursement agreements with the local supporting tissue banks.
• Setting up the local and national frameworks for the clinical trial, e.g. contact with local ethics committees and other involved institutions, submission of the respective forms and applications
• Implementation of the clinical trial, e.g. patient identification and information, operation and follow-up
• Support in the establishment of an ARISE registry
• Participation in dissemination activities at scientific congresses, publication of the results and public outreach activities

Principal investigators for UNIPD to ARISE

Prof. Dr. Giovanni Stellin, Professor, Director of Paediatric & Congenital, Cardiovascular Surgery Unit
Prof. Vladimiro Vida, Staff Pediatric and Congenital Cardiovascular Surgery Unit
Dr. Arben Dedja, Research Associate