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

Heart Valve Disease Clinical Trial

— ESPOIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035540
• Other study ID #: Surveillance Protocol 2013-11
• Secondary ID: FP7 2007-2013, N
• Status: Completed
• Start date: August 2014
• Est. completion date: January 2017

Study information

• Verified date: April 2022
• Source: corlife
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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®.

Related Conditions & MeSH terms

• Heart Valve Disease
• Heart Valve Diseases

Intervention

Other:
• Decellularized human valves

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Leuven, UZL	Leuven
France	Université Paris Descartes, UPD	Paris
Germany	Hannover Medical School	Hannover
Italy	Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP	Padova
Moldova, Republic of	Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU	Chisinau
Netherlands	Leids Universitair Medisch Centrum, LUMC	Leiden
Switzerland	Universitaet Zuerich, UZH, Switzerland	Zuerich
United Kingdom	Great Ormond Street Hospital for Children NHS Trust, GOSH	London

Sponsors (12)

Lead Sponsor

Collaborator

corlife

European Homograft Bank, German Society for Tissue Transplantation, Gottfried Wilhelm Leibniz Universität Hannover, Great Ormond Street Hospital for Children NHS Foundation Trust, Hannover Medical School, Hôpital Necker-Enfants Malades, Leiden University Medical Center, State University of Medicine and Pharmaceutics, Chisinau, Moldavia, Universitaire Ziekenhuizen Leuven, University of Padova, University of Zurich

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Moldova, Republic of,  Netherlands,  Switzerland,  United Kingdom, 

References & Publications (2)

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 p — View Citation

Boethig D, Horke A, Hazekamp M, Meyns B, Rega F, Van Puyvelde J, Hübler 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 p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of SARs (serious adverse reactions)	Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.	up to 24 months
Primary	Freedom from valve dysfunction	Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.	up to 24 months
Secondary	Blood Parameters	Blood Parameters as additional safety data to support presence/absence of Adverse Reactions	up to 24 months
Secondary	Diameters of ESPOIR PV at end of the study	Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation	after 24 months
Secondary	Time to reoperation	Time to reoperation due to explantation	up to to 24 months
Secondary	Time to death	Time to death	up to 24 months
Secondary	Evaluation of transvalvular gradients	valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging	up to 24 months

External Links

•   ESPOIR Website