European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR (ESPOIR)
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|ClinicalTrials.gov Identifier: NCT02035540|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : June 2, 2020
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.
|Condition or disease||Intervention/treatment|
|Heart Valve Disease||Other: Decellularized human valves|
|Study Type :||Observational|
|Actual Enrollment :||121 participants|
|Official Title:||European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
Decellularized human valves
Pulmonary heart valve replacement
Other: Decellularized human valves
Other Name: ESPOIR PV
- Amount of SARs (serious adverse reactions) [ Time Frame: up to 24 months ]Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.
- Freedom from valve dysfunction [ Time Frame: up to 24 months ]Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.
- Blood Parameters [ Time Frame: 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 [ Time Frame: after 24 months ]Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation
- Time to reoperation [ Time Frame: up to to 24 months ]Time to reoperation due to explantation
- Time to death [ Time Frame: up to 24 months ]Time to death
- Evaluation of transvalvular gradients [ Time Frame: up to 24 months ]valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035540
|Universitair Ziekenhuis Leuven, UZL|
|Leuven, Belgium, 3000|
|Université Paris Descartes, UPD|
|Paris, France, 75015|
|Hannover Medical School|
|Hannover, Germany, 30625|
|Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP|
|Padova, Italy, 35128|
|Moldova, Republic of|
|Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU|
|Chisinau, Moldova, Republic of, 2004|
|Leids Universitair Medisch Centrum, LUMC|
|Leiden, Netherlands, 2333|
|Universitaet Zuerich, UZH, Switzerland|
|Zuerich, Switzerland, 8032|
|Great Ormond Street Hospital for Children NHS Trust, GOSH|
|London, United Kingdom, WC1N 3JH|
|Principal Investigator:||Axel Haverich, Prof. Dr.||Hannover Medical School|
|Study Director:||Samir Sarikouch, PD Dr.||Hannover Medical School|