Last updated on August 2016

Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")


Brief description of study

Evaluation of decellularized human heart valves for aortic 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.

Detailed Study Description

This is a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where - ARISE AV is prescribed in the usual manner in accordance with the terms of the approval. - 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 ARISE AV 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.

Clinical Study Identifier: NCT02527629

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Bart Meyns, Prof. Dr.

Universitair Ziekenhuis Leuven, UZL
Leuven, Belgium
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Artur Lichtenberg, Prof. Dr.

University of D sseldorf, Department of Cardiovascular Surgery
Düsseldorf, Germany
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Axel Haverich, Prof. Dr.

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

Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite
Padova, Italy
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Mark G Hazekamp, Prof. Dr.

Leids Universitair Medisch Centrum, LUMC
Leiden, Netherlands
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José L Pomar, Prof. Dr.

University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area
Barcelona, Spain
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Michael Hübler, Prof.

Kinderspital Z rich
Zürich, Switzerland
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John Pepper, Prof. Dr.

Royal Brompton and Harefield National Health Service Trust
London, United Kingdom
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