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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Valve Disease

Intervention / Treatment
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* Other: Decellularized human valves


Participation Criteria
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Eligibility Criteria
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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®.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Decellularized human valves<br>Pulmonary heart valve replacement | Other: Decellularized human valves<br> <br> * Other names: ESPOIR PV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of SARs (serious adverse reactions) | Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc. | up to 24 months | 
| Freedom from valve dysfunction | Freedom from valve dysfunction leading to re-intervention or explantation at end of the study. | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Parameters | Blood Parameters as additional safety data to support presence/absence of Adverse Reactions | up to 24 months | 
| Diameters of ESPOIR PV at end of the study | Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation | after 24 months | 
| Time to reoperation | Time to reoperation due to explantation | up to to 24 months | 
| Time to death | Time to death | up to 24 months | 
| Evaluation of transvalvular gradients | valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging | up to 24 months |