Heart Valve Disease Clinical Trial
Official title:
Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")
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.
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.
;
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