Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005936

Trial Description

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Title

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

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Trial Acronym

ESPOIR

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URL of the Trial

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Brief Summary in Lay Language

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 PV (pulmonary valve) 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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005936
  •   2014/08/25
  •   2014/01/10
  •   no
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Secondary IDs

  •   NCT02035540  (ClinicalTrials.gov)
  •   Surveillance Protocol 2013-11  (corlife)
  •   FP7 2007-2013, No. 278453 
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Health Condition or Problem studied

  •   Heart Valve Disease
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Interventions/Observational Groups

  •   Other: Decellularized human valves
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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.

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Secondary Outcome

- 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

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Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Italy
  •   United Kingdom
  •   Netherlands
  •   Switzerland
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Locations of Recruitment

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Recruitment

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  •   2014/08/31
  •   200
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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.

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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®.

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Addresses

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    • corlife
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    • Hannover Medical School
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    • State University of Medicine and Pharmaceutics, Chisinau, Moldavia
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    • Leiden University Medical Center
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    • Great Ormond Street Hospital for Children NHS Foundation Trust
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    • University of Padova
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    • Hôpital Necker-Enfants Malades
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    • University of Zurich
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    • Universitaire Ziekenhuizen Leuven
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    • German Society for Tissue Transplantation
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    • European Homograft Bank, Belgium
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    • Gottfried Wilhelm Leibniz Universität Hannover
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    • Hannover Medical School
    • Axel Haverich, Prof. Dr. 
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    • Samir Sarikouch, PD MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   2
  •   2014/11/27
* This entry means the parameter is not applicable or has not been set.