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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035540
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : June 2, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
corlife

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.


Condition or disease Intervention/treatment
Heart Valve Disease Other: Decellularized human valves

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Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Decellularized human valves
Pulmonary heart valve replacement
Other: Decellularized human valves
Other Name: ESPOIR PV




Primary Outcome Measures :
  1. Amount of SARs (serious adverse reactions) [ Time Frame: up to 24 months ]
    Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.

  2. 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.


Secondary Outcome Measures :
  1. Blood Parameters [ Time Frame: up to 24 months ]
    Blood Parameters as additional safety data to support presence/absence of Adverse Reactions

  2. 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

  3. Time to reoperation [ Time Frame: up to to 24 months ]
    Time to reoperation due to explantation

  4. Time to death [ Time Frame: up to 24 months ]
    Time to death

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acquired and congenital heart disease requiring heart valve replacement.
Criteria

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®.

Information from the National Library of Medicine

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


Locations
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Belgium
Universitair Ziekenhuis Leuven, UZL
Leuven, Belgium, 3000
France
Université Paris Descartes, UPD
Paris, France, 75015
Germany
Hannover Medical School
Hannover, Germany, 30625
Italy
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
Netherlands
Leids Universitair Medisch Centrum, LUMC
Leiden, Netherlands, 2333
Switzerland
Universitaet Zuerich, UZH, Switzerland
Zuerich, Switzerland, 8032
United Kingdom
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
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Principal Investigator: Axel Haverich, Prof. Dr. Hannover Medical School
Study Director: Samir Sarikouch, PD Dr. Hannover Medical School
Additional Information:
Study Data/Documents: Study results  This link exits the ClinicalTrials.gov site

Publications of Results:
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Responsible Party: corlife
ClinicalTrials.gov Identifier: NCT02035540    
Other Study ID Numbers: Surveillance Protocol 2013-11
FP7 2007-2013, No. 278453 ( Other Grant/Funding Number: European Commission )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020
Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases