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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 May 2022 |
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Main ID: |
NCT02035540 |
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Date of registration:
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10/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
ESPOIR |
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Scientific title:
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European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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121 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02035540 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Moldova, Republic of
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Netherlands
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Switzerland
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United Kingdom
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Contacts
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Name:
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Samir Sarikouch, PD Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hannover Medical School |
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Name:
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Axel Haverich, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hannover Medical School |
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Key inclusion & exclusion criteria
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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®.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Valve Disease
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Intervention(s)
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Other: Decellularized human valves
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Primary Outcome(s)
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Amount of SARs (serious adverse reactions)
[Time Frame: up to 24 months]
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Freedom from valve dysfunction
[Time Frame: up to 24 months]
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Secondary Outcome(s)
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Diameters of ESPOIR PV at end of the study
[Time Frame: after 24 months]
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Time to reoperation
[Time Frame: up to to 24 months]
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Blood Parameters
[Time Frame: up to 24 months]
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Evaluation of transvalvular gradients
[Time Frame: up to 24 months]
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Time to death
[Time Frame: up to 24 months]
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Secondary ID(s)
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FP7 2007-2013, No. 278453
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Surveillance Protocol 2013-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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