Study identification

EU PAS number

EUPAS10201

Study ID

35523

Official title and acronym

Aortic Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the “Surveillance”)

DARWIN EU® study

No

Study countries

Austria
Belgium
Germany
Italy
Netherlands
Spain
United Kingdom

Study description

The purpose of this investigation is to evaluate decellularized human aortic valve, Arise AV (“ARISE AV”) for aortic valve replacement rates in comparison to current valve substitutes within a large prospective multicentre surveillance at 6 leading European Centres for Cardiothoracic Surgery regarding re-operation and re-intervention, hemodynamic performance, growth potential and long term durability. More qualified centres may be added to supplement the Surveillance cohort. Primary safety endpoints: All‐cause mortality, major stroke, life‐threatening (or disabling) bleeding, acute kidney injury—stage 3 (including renal replacement therapy), peri‐procedural myocardial infarction, major vascular complication, repeat procedure for valve‐related dysfunction (surgical or interventional therapy.Secondary safety data: Collection of medical data to assess the process of tissue vigilance. Collection of medical history to support the presence/absence of adverse events, e.g. infections, arrhythmia.Primary efficacy endpoint: Freedom from valve dysfunction leading to re-intervention or explanation at end of the Surveillance.Key secondary efficacy endpoint: Diameters of ARISE AV at end of the Surveillance in comparison to diameters at implantation, transvalvular gradients, valve competence assessed by non-invasive imaging tools such as echocardiography or cardiac magnetic resonance imaging.

Study status

Finalised
Research institutions and networks

Institutions

Academisch Ziekenhuis Leiden - Leids Universitair Medisch Centrum (LUMC) Leiden, Netherlands, Università degli Studi di Padova (UNIPD) Padova, Italy, University Hospital Clinic de Barcelona Barcelona, Spain, Royal Brompton and Harefield National Health Service Trust London, UK, Universitair Ziekenhuis Leuven (UZL) Leuven, Belgium, Universitätsklinikum Düsseldorf Klinik für Kardiovaskuläre Chirurgie Düsseldorf, Germany, Allgemeines Krankenhaus der Stadt Wien Vienna, Austria

Contact details

Axel Haverich

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme

More details on funding

European Commission Project # 643597 Arise
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable