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

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.

Study Overview

• Status: Completed
• Conditions: Heart Valve Disease
• Intervention / Treatment: Other: Decellularized human valves

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven, UZL
• France
  • Paris, France, 75015
    • Université Paris Descartes, UPD
• Germany
  • Hannover, Germany, 30625
    • Hannover Medical School
• Italy
  • Padova, Italy, 35128
    • Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP
• Moldova, Republic of
  • Chisinau, Moldova, Republic of, 2004
    • Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU
• Netherlands
  • Leiden, Netherlands, 2333
    • Leids Universitair Medisch Centrum, LUMC
• Switzerland
  • Zuerich, Switzerland, 8032
    • Universitaet Zuerich, UZH, Switzerland
• United Kingdom
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital for Children NHS Trust, GOSH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acquired and congenital heart disease requiring heart valve replacement.

Description

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®.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Decellularized human valves; Pulmonary heart valve replacement	Other: Decellularized human valves; Other Names: ESPOIR PV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of SARs (serious adverse reactions)	Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.	up to 24 months
Freedom from valve dysfunction	Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Parameters	Blood Parameters as additional safety data to support presence/absence of Adverse Reactions	up to 24 months
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
Time to reoperation	Time to reoperation due to explantation	up to to 24 months
Time to death	Time to death	up to 24 months
Evaluation of transvalvular gradients	valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging	up to 24 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• ESPOIR Website

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): January 1, 2017
• Study Completion (ACTUAL): January 1, 2017

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (ESTIMATE): January 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases
• Other Study ID Numbers: Surveillance Protocol 2013-11; FP7 2007-2013, No. 278453 (OTHER_GRANT: European Commission)

Plan for Individual participant data (IPD)

Study Data/Documents

1. Study results