Heart Valve Disease
Conditions
Brief summary
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.
Interventions
OTHERDecellularized human valves
Sponsors
Hannover Medical School
State University of Medicine and Pharmaceutics, Chisinau, Moldavia
Leiden University Medical Center
Great Ormond Street Hospital for Children NHS Foundation Trust
University of Padova
Hôpital Necker-Enfants Malades
University of Zurich
Universitaire Ziekenhuizen KU Leuven
German Society for Tissue Transplantation
European Homograft Bank
Gottfried Wilhelm Leibniz Universität Hannover
corlife
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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®.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of SARs (serious adverse reactions) | up to 24 months | Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc. |
| Freedom from valve dysfunction | up to 24 months | Freedom from valve dysfunction leading to re-intervention or explantation at end of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reoperation | up to to 24 months | Time to reoperation due to explantation |
| Blood Parameters | up to 24 months | Blood Parameters as additional safety data to support presence/absence of Adverse Reactions |
| Evaluation of transvalvular gradients | up to 24 months | valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging |
| Time to death | up to 24 months | Time to death |
| Diameters of ESPOIR PV at end of the study | after 24 months | Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation |
Countries
Belgium, France, Germany, Italy, Moldova, Netherlands, Switzerland, United Kingdom
Outcome results
None listed