European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

Summary

This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where

* ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
* The assignment of the patient to a particular therapeutic strategy is not decided in advance by this Surveillance Protocol but falls within current practice and the prescription of ESPOIR PV is clearly separated from the decision to include the patient in the Surveillance.
* No additional diagnostic or monitoring procedures shall be applied to the patients
* and epidemiological methods shall be used for the analysis of collected data.

Evaluation of decellularized human heart valves for pulmonary heart valve replacement in comparison to current valve substitutes. Safety endpoints include cardiovascular adverse events, time to re-operation, re-intervention and explantation. Efficacy endpoints include freedom from valve dysfunction and hemodynamic performance.

Conditions

• Heart Valve Disease

Interventions

OTHER

Decellularized human valves

Sponsors & Collaborators

• Hannover Medical School

  collaborator OTHER

• State University of Medicine and Pharmaceutics, Chisinau, Moldavia

  collaborator UNKNOWN

• Leiden University Medical Center

  collaborator OTHER

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• University of Padova

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• German Society for Tissue Transplantation

  collaborator OTHER

• European Homograft Bank

  collaborator OTHER

• Gottfried Wilhelm Leibniz Universität Hannover

  collaborator OTHER

• corlife

  lead INDUSTRY

Principal Investigators

• Axel Haverich, Prof. Dr. · Hannover Medical School

• Samir Sarikouch, PD Dr. · Hannover Medical School

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2017-01-31

Completion

2017-01-31

Countries

• Belgium
• France
• Germany
• Italy
• Moldova
• Netherlands
• Switzerland
• United Kingdom

Study Locations