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

corlife

Status: Completed

Conditions: Heart Valve Disease

Treatments: Other: Decellularized human heart valves

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02527629

Grant Agreement No: 643597 (Other Grant/Funding Number)

2015- 01, 20.07.2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Volunteers: No Healthy Volunteers

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®.

Trial design

144 participants in 1 patient group

Decellularized human valves

Description:

Aortic heart valve replacement

Treatment:

Other: Decellularized human heart valves