Status: Finalised First registered on: 27/01/2014
Last updated on: 26/04/2022
1. Study identification
EU PAS Register NumberEUPAS5064
Official titleEuropean Clinical Study for the Application of Regenerative Heart Valves
Study title acronymESPOIR
Study typeActive surveillance
Brief description of the studyBoth acquired and congenital heart disease can require heart valve replacement. Currently available heart valve substitutes are, however, not ideal as they require anticoagulation, with the risk of bleeding when manufactured from non-organic material, or they degenerate when derived from animals (xenografts) or human tissue donors (homografts), leading to the need for frequent reoperation, especially in children and young adults. An ideal heart valve substitute would have the potential to grow even when implanted in paediatric patients. ESPOIR PV hosts the power to regenerate. The purpose of this investigation is to evaluate decellularized human pulmonary valve, Espoir PV (“ESPOIR PV”) for pulmonary valve replacement rates in comparison to current valve substitutes within a large prospective multicentre surveillance at 8 leading European Centres for Congenital Cardiothoracic Surgery regarding re-operation and re-intervention, hemodynamic performance, growth potential and long term durability. Primary safety endpoints: Rate of cardiovascular adverse reactions, leading to e.g. re-operation, catheter based interventions. 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 ESPOIR PV 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 applicableNCT02035540
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

Hannover Medical School HTTG, Hannover, Germany
Universitatea de Stat de Medicina si Farmacie „Nicolae Testemitanu“, Cisinau, Moldova
Academisch Ziekenhuis Leiden - Leids Universitair Medisch Centrum, Leiden, Netherlands
Great Ormond Street Hospital for Children NHS Trust, London, United Kingdom
Università degli studi di Padova; Azienda Ospedaliera di Padova, Padua, Italy
Université Paris Descartes, Paris, France
Universitaet Zuerich, Zürich, Switzerland
Universitair Ziekenhuis Leuven, Leuven, Belgium
Countries in which this study is being conducted
International study

Belgium
France
Germany
Italy
Moldova, Republic of
Netherlands
Switzerland
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed22/12/2011
Start date of data collection15/06/201405/08/2014
Start date of data analysis02/01/201701/03/2017
Date of interim report, if expected
Date of final study report31/03/201831/01/2019
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 # 278453100
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-Neuberg-Str. 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 Katrin 
First name Fuchs 
Address line 1Medizinische Hochschule Hannover 
Address line 2Dep. for Cardiothoracic, Transplantation & Vascular Surgery 
Address line 3Carl-Neuberg-Str. 1 
CityHannover 
Postcode30625 
CountryGermany 
Phone number (incl. country code)49-511-5327849 
Alternative phone number 
Fax number (incl. country code)49-511-53218507 
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