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| ID | Type | Description | Link |
|---|---|---|---|
| FP7 2007-2013, No. 278453 | Other Grant/Funding Number | European Commission |
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| Name | Class |
|---|---|
| Hannover Medical School | OTHER |
| State University of Medicine and Pharmaceutics, Chisinau, Moldavia | UNKNOWN |
| Leiden University Medical Center | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decellularized human valves | Pulmonary heart valve replacement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decellularized human valves | Other |
|
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The patient has not provided Surveillance informed consent.
The patient shall not suffer from
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®.
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Patients with acquired and congenital heart disease requiring heart valve replacement.
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| Name | Affiliation | Role |
|---|---|---|
| Axel Haverich, Prof. Dr. | Hannover Medical School | Principal Investigator |
| Samir Sarikouch, PD Dr. | Hannover Medical School | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Leuven, UZL | Leuven | 3000 | Belgium | |||
| Université Paris Descartes, UPD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30879050 | Result | Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hubler M, Schmiady M, Ciubotaru A, Stellin G, Padalino M, Tsang V, Jashari R, Bobylev D, Tudorache I, Cebotari S, Haverich A, Sarikouch S. A European study on decellularized homografts for pulmonary valve replacement: initial results from the prospective ESPOIR Trial and ESPOIR Registry datadagger. Eur J Cardiothorac Surg. 2019 Sep 1;56(3):503-509. doi: 10.1093/ejcts/ezz054. | |
| 35425983 |
| Label | URL |
|---|---|
| ESPOIR Website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study results | View IPD |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Great Ormond Street Hospital for Children NHS Foundation Trust |
| OTHER |
| University of Padova | OTHER |
| Hôpital Necker-Enfants Malades | OTHER |
| University of Zurich | OTHER |
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| German Society for Tissue Transplantation | OTHER |
| European Homograft Bank | OTHER |
| Gottfried Wilhelm Leibniz Universität Hannover | OTHER |
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| 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 |
| Paris |
| 75015 |
| France |
| Hannover Medical School | Hanover | 30625 | Germany |
| Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP | Padova | 35128 | Italy |
| Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU | Chisinau | 2004 | Moldova |
| Leids Universitair Medisch Centrum, LUMC | Leiden | 2333 | Netherlands |
| Universitaet Zuerich, UZH, Switzerland | Zurich | 8032 | Switzerland |
| Great Ormond Street Hospital for Children NHS Trust, GOSH | London | WC1N 3JH | United Kingdom |
| Result |
| Bobylev D, Horke A, Boethig D, Hazekamp M, Meyns B, Rega F, Dave H, Schmiady M, Ciubotaru A, Cheptanaru E, Vida V, Padalino M, Tsang V, Jashari R, Laufer G, Andreas M, Andreeva A, Tudorache I, Cebotari S, Haverich A, Sarikouch S. 5-Year results from the prospective European multi-centre study on decellularized homografts for pulmonary valve replacement ESPOIR Trial and ESPOIR Registry data. Eur J Cardiothorac Surg. 2022 Oct 4;62(5):ezac219. doi: 10.1093/ejcts/ezac219. |