Clinical trial NCT02527629: Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")
Official title: Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Disease
Lead sponsor: corlife
Sponsor class: INDUSTRY
Collaborators: name: Hannover Medical School
name: Leiden University Medical Center
name: Azienda Ospedaliera di Padova
name: Hospital Clinic of Barcelona
name: Royal Brompton & Harefield NHS Foundation Trust
name: Universitaire Ziekenhuizen KU Leuven
name: Heinrich-Heine University, Duesseldorf
name: Vienna General Hospital
First posted: 2015-08-19
Enrollment: 144
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe aortic valve disease and the indication for aortic valve replacement

Brief summary: 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 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.

Eligibility criteria: Inclusion Criteria:

i. Indication for aortic valve replacement according to current medical guidelines in valvular heart disease

ii. Informed consent of legal guardians or patients, assent of patients

Exclusion Criteria:

i. The patient has not provided Surveillance informed consent.

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®.

Primary outcomes:
measure: Cardiovascular Adverse Reactions (AR)
timeFrame: up to 24 months
measure: Freedom from valve dysfunction at end of the study
timeFrame: up to 24 months
Secondary outcomes:
measure: Evaluation of composite blood parameters
timeFrame: up to 24 months
measure: Time to reoperation and / or death
timeFrame: up to 24 months
measure: Evaluation of composite valve measures
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven, UZL
city: Düsseldorf
country: Germany
facility: University of Düsseldorf, Department of Cardiovascular Surgery
city: Hannover
country: Germany
facility: Hannover Medical School
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova, U.O.C. di Cardiochirurgia Pediatrica e Cardiopatie Congenite
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum, LUMC
city: Barcelona
country: Spain
facility: University Hospital Clinic de Barcelona, Cardiovascular Surgery administrative area
city: Zürich
country: Switzerland
facility: Kinderspital Zürich
city: London
country: United Kingdom
facility: Royal Brompton and Harefield National Health Service Trust
Study officials:
affiliation: Hannover Medical School
name: Axel Haverich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Samir Sarikouch, PD Dr.
role: STUDY_DIRECTOR
References:
citation: 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.