Aortic Replacement using individualised regenerative Allografts- ARISE
Research type
Research Study
Full title
Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE
IRAS ID
200467
Contact name
Nicolin Heister
Contact email
Sponsor organisation
corlife oHG
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
10201, EU PAS Registry
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
65,000 aortic valve replacements (AVR) are performed in Europe each year to treat acquired and congenital aortic valve disease. Mortality without AVR is extremely high when symptoms occur and 50 % of affected patients die within 2 years. Current AVR options are, however, limited for young patients - especially female patients - and those unwilling to accept life-long medical anticoagulation with its inherent risks. None of the currently available prostheses for AVR is tailored toward the individual patient or allows for individual regeneration.This is a prospective, non-randomized, single-arm, multi-centre surveillance study to be conducted in Europe. This study will include 120 patients from 6 leading European Centres for Congenital Cardiothoracic Surgery. These patients will receive the Arise AV valve instead of a traditional homograft valve, and their routine follow-up data will be anonymously documented in the common, European database.
The Study is designed as a study, where
◦ ARISE AV is prescribed in the usual manner in accordance with the terms of the market 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.
◦ Epidemiological methods shall be used for the analysis of collected data.REC name
London - Brent Research Ethics Committee
REC reference
16/LO/1687
Date of REC Opinion
30 Sep 2016
REC opinion
Favourable Opinion