Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
NCT ID: NCT02527629
Last Updated: 2020-06-02
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
144 participants
OBSERVATIONAL
2015-09-30
2019-03-31
Brief Summary
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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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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Decellularized human valves
Aortic heart valve replacement
Decellularized human heart valves
Decellularized human aortic heart valves
Interventions
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Decellularized human heart valves
Decellularized human aortic heart valves
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
ii. Informed consent of legal guardians or patients, assent of patients
Exclusion Criteria
ii. 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.
iii. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
iv. 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
Leiden University Medical Center
OTHER
Azienda Ospedaliera di Padova
OTHER
Hospital Clinic of Barcelona
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
Heinrich-Heine University, Duesseldorf
OTHER
Vienna General Hospital
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
University of Düsseldorf, Department of Cardiovascular Surgery
Düsseldorf, , Germany
Hannover Medical School
Hanover, , Germany
Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite
Padua, , Italy
Leids Universitair Medisch Centrum, LUMC
Leiden, , Netherlands
University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area
Barcelona, , Spain
Kinderspital Zürich
Zurich, , Switzerland
Royal Brompton and Harefield National Health Service Trust
London, , United Kingdom
Countries
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References
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Horke A, Tudorache I, Laufer G, Andreas M, Pomar JL, Pereda D, Quintana E, Sitges M, Meyns B, Rega F, Hazekamp M, Hubler M, Schmiady M, Pepper J, Rosendahl U, Lichtenberg A, Akhyari P, Jashari R, Boethig D, Bobylev D, Avsar M, Cebotari S, Haverich A, Sarikouch S. Early results from a prospective, single-arm European trial on decellularized allografts for aortic valve replacement: the ARISE study and ARISE Registry data. Eur J Cardiothorac Surg. 2020 Nov 1;58(5):1045-1053. doi: 10.1093/ejcts/ezaa100.
Study Documents
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Document Type: Study results
View DocumentOther Identifiers
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Grant Agreement No: 643597
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2015- 01, 20.07.2015
Identifier Type: -
Identifier Source: org_study_id
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