European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
Study Details
Study Description
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
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ESPOIR pulmonary valve (PV) is prescribed in the usual manner in accordance with the terms of the approval.
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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.
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No additional diagnostic or monitoring procedures shall be applied to the patients
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Decellularized human valves Pulmonary heart valve replacement |
Other: Decellularized human valves
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Blood Parameters [up to 24 months]
Blood Parameters as additional safety data to support presence/absence of Adverse Reactions
- 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
- Time to reoperation [up to to 24 months]
Time to reoperation due to explantation
- Time to death [up to 24 months]
Time to death
- Evaluation of transvalvular gradients [up to 24 months]
valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging
Eligibility Criteria
Criteria
Inclusion Criteria:
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Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
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Signed Informed consent of legal guardians or patients, assent of patients.
Exclusion Criteria:
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The patient has not provided Surveillance informed consent.
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The patient shall not suffer from
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generalized connective tissue disorders (eg, Marfan syndrome), or
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active rheumatic disorders, or
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severe asymmetric calcification of the valve ring.
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The coronary arteries of the patient shall not be in abnormal position or heavily calcified.
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Patients shall not show hypersensitivity against Sodium Dodecyl Sulphate (SDS), Sodium Desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitair Ziekenhuis Leuven, UZL | Leuven | Belgium | 3000 | |
| 2 | Université Paris Descartes, UPD | Paris | France | 75015 | |
| 3 | Hannover Medical School | Hannover | Germany | 30625 | |
| 4 | Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP | Padova | Italy | 35128 | |
| 5 | Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU | Chisinau | Moldova, Republic of | 2004 | |
| 6 | Leids Universitair Medisch Centrum, LUMC | Leiden | Netherlands | 2333 | |
| 7 | Universitaet Zuerich, UZH, Switzerland | Zuerich | Switzerland | 8032 | |
| 8 | Great Ormond Street Hospital for Children NHS Trust, GOSH | London | United Kingdom | WC1N 3JH |
Sponsors and Collaborators
- corlife
- 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 Leuven
- German Society for Tissue Transplantation
- European Homograft Bank
- Gottfried Wilhelm Leibniz Universität Hannover
Investigators
- Principal Investigator: Axel Haverich, Prof. Dr., Hannover Medical School
- Study Director: Samir Sarikouch, PD Dr., Hannover Medical School
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- Surveillance Protocol 2013-11
- FP7 2007-2013, No. 278453