NCT02527629

Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")

Aortic Replacement Using Individualised Regenerative Allografts: Bridging the Therapeutic Gap - ARISE (the "Surveillance")

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 144 (actual)
• Sponsor: corlife · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Valve Disease

Interventions

Type	Name	Description
OTHER	Decellularized human heart valves	Decellularized human aortic heart valves

Timeline

• Start date: 2015-09-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2015-08-19
• Last updated: 2020-06-02

Locations

8 sites across 7 countries: Belgium, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom