Last updated on January 2017

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

Brief description of study

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 PV (pulmonary valve) 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.

Clinical Study Identifier: NCT02035540

Contact Investigators or Research Sites near you

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Bart Meyns, Prof. Dr.

Universitair Ziekenhuis Leuven, UZL
Leuven, Belgium
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Pascale Vouhe, Prof.

Universit Paris Descartes, UPD
Paris, France
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Axel Haverich, Prof. Dr.

Hannover Medical School
Hannover, Germany
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Giovanni Stellin, Prof. Dr.

Universit degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP
Padova, Italy
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Anatol Ciubotaru, Prof. Dr.

Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU
Chisinau, Moldova, Republic of
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Mark G Hazekamp, Prof. Dr.

Leids Universitair Medisch Centrum, LUMC
Leiden, Netherlands
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Michael Hübler, Prof. Dr.

Universitaet Zuerich, UZH, Switzerland
Zuerich, Switzerland
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Victor Tsang

Great Ormond Street Hospital for Children NHS Trust, GOSH
London, United Kingdom
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