European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR

This is a prospective, non-randomized, single-arm, multicentre surveillance study to be conducted in Europe. The Surveillance is designed as a study, where

• ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
• The 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 ESPOIR PV 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.

Evaluation of decellularized human heart valves for pulmonary 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.

Inclusion Criteria:

• Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
• Signed Informed consent of legal guardians or patients, assent of patients.

Exclusion Criteria:

• The patient has not provided Surveillance informed consent.

• 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.

• The coronary arteries of the patient shall not be in abnormal position or heavily calcified.

• Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.