Clinical trial NCT02035540: European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
Official title: European Clinical Study for the Application of Regenerative Heart Valves - ESPOIR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Disease
Lead sponsor: corlife
Sponsor class: INDUSTRY
Collaborators: name: Hannover Medical School
name: State University of Medicine and Pharmaceutics, Chisinau, Moldavia
name: Leiden University Medical Center
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: University of Padova
name: Hôpital Necker-Enfants Malades
name: University of Zurich
name: Universitaire Ziekenhuizen KU Leuven
name: German Society for Tissue Transplantation
name: European Homograft Bank
name: Gottfried Wilhelm Leibniz Universität Hannover
First posted: 2014-01-14
Enrollment: 121
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acquired and congenital heart disease requiring heart valve replacement.

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.


Eligibility 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®.

Primary outcomes:
measure: Amount of SARs (serious adverse reactions)
timeFrame: up to 24 months
measure: Freedom from valve dysfunction
timeFrame: up to 24 months
Secondary outcomes:
measure: Blood Parameters
timeFrame: up to 24 months
measure: Diameters of ESPOIR PV at end of the study
timeFrame: after 24 months
measure: Time to reoperation
timeFrame: up to to 24 months
measure: Time to death
timeFrame: up to 24 months
measure: Evaluation of transvalvular gradients
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven, UZL
city: Paris
country: France
facility: Université Paris Descartes, UPD
city: Hannover
country: Germany
facility: Hannover Medical School
city: Padova
country: Italy
facility: Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP
city: Chisinau
country: Moldova, Republic of
facility: Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum, LUMC
city: Zuerich
country: Switzerland
facility: Universitaet Zuerich, UZH, Switzerland
city: London
country: United Kingdom
facility: Great Ormond Street Hospital for Children NHS Trust, GOSH
Study officials:
affiliation: Hannover Medical School
name: Axel Haverich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Samir Sarikouch, PD Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.