European Clinical Study for the Application of Regenerative Heart Valves – ESPOIR (the “Surveillance”)

Study identification

• EU PAS number:
  EUPAS5064
• Study ID:
  46898
• Official title and acronym:
  European Clinical Study for the Application of Regenerative Heart Valves – ESPOIR (the “Surveillance”)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy

  Moldova, Republic of

  Netherlands

  Switzerland

  United Kingdom
• Study description:
  Both 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School

Germany

Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School

Germany

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

Study timelines

Date when funding contract was signed

Actual:22/12/2011

Study start date

Planned:15/06/2014

Actual:05/08/2014

Data analysis start date

Planned:02/01/2017

Actual:01/03/2017

Date of final study report

Planned:31/03/2018

Actual:31/01/2019

Sources of funding

EU institutional research programme

More details on funding

European Commission, Project # 278453

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

NCT02035540