Status: Finalised First registered on: 24/07/2015
Last updated on: 29/05/2020
1. Study identification
EU PAS Register NumberEUPAS10201
Official titleAortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE
Study title acronymARISE
Study typeActive surveillance
Brief description of the studyThe purpose of this investigation is to evaluate decellularized human aortic valve, Arise AV (“ARISE AV”) for aortic valve replacement rates in comparison to current valve substitutes within a large prospective multicentre surveillance at 6 leading European Centres for Cardiothoracic Surgery regarding re-operation and re-intervention, hemodynamic performance, growth potential and long term durability. More qualified centres may be added to supplement the Surveillance cohort. Primary safety endpoints: All‐cause mortality, major stroke, life‐threatening (or disabling) bleeding, acute kidney injury—stage 3 (including renal replacement therapy), peri‐procedural myocardial infarction, major vascular complication, repeat procedure for valve‐related dysfunction (surgical or interventional therapy. Secondary safety data: Collection of medical data to assess the process of tissue vigilance. Collection of medical history to support the presence/absence of adverse events, e.g. infections, arrhythmia. Primary efficacy endpoint: Freedom from valve dysfunction leading to re-intervention or explanation at end of the Surveillance. Key secondary efficacy endpoint: Diameters of ARISE AV at end of the Surveillance in comparison to diameters at implantation, transvalvular gradients, valve competence assessed by non-invasive imaging tools such as echocardiography or cardiac magnetic resonance imaging.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableNCT 02527629
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsHannover Medical School HTTG
Department/Research groupCardiothoracic, Transplant, and Vascular Surgery
Organisation/affiliationHannover Medical School
Website/Homepagehttp://www.mh-hannover.de
Details of (Primary) lead investigator
Title Professor
Last name Haverich
First name Axel
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?8

Academisch Ziekenhuis Leiden - Leids Universitair Medisch Centrum (LUMC), Leiden, Netherlands
Università degli Studi di Padova (UNIPD), Padova, Italy
University Hospital Clinic de Barcelona, Barcelona, Spain
Royal Brompton and Harefield National Health Service Trust, London, UK
Universitair Ziekenhuis Leuven (UZL), Leuven, Belgium
Universitätsklinikum Düsseldorf Klinik für Kardiovaskuläre Chirurgie, Düsseldorf, Germany
Allgemeines Krankenhaus der Stadt Wien, Vienna, Austria
Countries in which this study is being conducted
International study

Austria
Belgium
Germany
Italy
Netherlands
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/12/2014
Start date of data collection31/01/201624/09/2015
Start date of data analysis31/01/2019
Date of interim report, if expected
Date of final study report31/03/201908/11/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeEuropean Commission Project # 643597 Arise100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Sarikouch
First name Samir
Address line 1Medizinische Hochschule Hannover
Address line 2Dep. for Cardiothoracic, Transplantation Vascular Surgery 
Address line 3Carl-Neubergstr. 1 
CityHannover 
Postcode30625 
CountryGermany
Phone number (incl. country code)49-511-5325567 
Alternative phone number 
Fax number (incl. country code)49-511-53218507 
Public Enquiries
Title Mrs 
Last name Fuchs 
First name Katrin 
Address line 1Medizinische Hochschule Hannover 
Address line 2Dep. for Cardiothoracic, Transplantation Vascular Surgery 
Address line 3Carl-Neubergstr. 1 
CityHannover 
Postcode30625 
CountryGermany 
Phone number (incl. country code)495115327849 
Alternative phone number 
Fax number (incl. country code)4951153218507 
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