European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
NCT ID: NCT02035540
Last Updated: 2022-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2014-08-31
2017-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Decellularized human valves
Pulmonary heart valve replacement
Decellularized human valves
Interventions
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Decellularized human valves
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed Informed consent of legal guardians or patients, assent of patients.
Exclusion Criteria
* The patient shall not suffer from
* generalized connective tissue disorders (eg, Marfan syndrome), or
* active rheumatic disorders, or
* severe asymmetric calcification of the valve ring.
* The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
* Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
ALL
No
Sponsors
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Hannover Medical School
OTHER
State University of Medicine and Pharmaceutics, Chisinau, Moldavia
UNKNOWN
Leiden University Medical Center
OTHER
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
University of Padova
OTHER
Hôpital Necker-Enfants Malades
OTHER
University of Zurich
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
German Society for Tissue Transplantation
OTHER
European Homograft Bank
OTHER
Gottfried Wilhelm Leibniz Universität Hannover
OTHER
corlife
INDUSTRY
Responsible Party
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Principal Investigators
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Axel Haverich, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Samir Sarikouch, PD Dr.
Role: STUDY_DIRECTOR
Hannover Medical School
Locations
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Universitair Ziekenhuis Leuven, UZL
Leuven, , Belgium
Université Paris Descartes, UPD
Paris, , France
Hannover Medical School
Hanover, , Germany
Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP
Padua, , Italy
Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU
Chisinau, , Moldova
Leids Universitair Medisch Centrum, LUMC
Leiden, , Netherlands
Universitaet Zuerich, UZH, Switzerland
Zurich, , Switzerland
Great Ormond Street Hospital for Children NHS Trust, GOSH
London, , United Kingdom
Countries
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References
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Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hubler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry datadagger. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054.
Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac219. doi: 10.1093/ejcts/ezac219.
Study Documents
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Document Type: Study results
View DocumentRelated Links
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ESPOIR Website
Other Identifiers
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FP7 2007-2013, No. 278453
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Surveillance Protocol 2013-11
Identifier Type: -
Identifier Source: org_study_id
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