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

NCT02035540 | Completed DMC

• 2 other identifiers: Surveillance Protocol 2013-11FP7 2007-2013, No. 278453
• Study Type: observational
• Target: 121
• Locations: 8 countries
• Sites: 8

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.

Conditions

Heart Valve Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Blood Parameters

  up to 24 months

• Diameters of ESPOIR PV at end of the study

  after 24 months

• Time to reoperation

  up to to 24 months

• Time to death

  up to 24 months

• Evaluation of transvalvular gradients

  up to 24 months

Study Arms (1)

Decellularized human valves

Pulmonary heart valve replacement

Other: Decellularized human valves

Interventions

Decellularized human valves OTHER

Also known as: ESPOIR PV

Decellularized human valves

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Indication for pulmonary valve replacement according to current medical guidelines in heart disease.
• Signed Informed consent of legal guardians or patients, assent of patients.

You may not qualify if:

• 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®.

Sponsors & Collaborators

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

Study Sites (8)

Universitair Ziekenhuis Leuven, UZL

Leuven, 3000, Belgium

Location

Université Paris Descartes, UPD

Paris, 75015, France

Location

Hannover Medical School

Hanover, 30625, Germany

Location

Università degli studi di Padova, Azienda Ospedaliera di Padova, UNIPD/AOP

Padua, 35128, Italy

Location

Universitatea de Stat de Medicina si Farmacie "Nicolae Testemitanu", SMPHU

Chisinau, 2004, Moldova

Location

Leids Universitair Medisch Centrum, LUMC

Leiden, 2333, Netherlands

Location

Universitaet Zuerich, UZH, Switzerland

Zurich, 8032, Switzerland

Location

Great Ormond Street Hospital for Children NHS Trust, GOSH

London, WC1N 3JH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30879050 RESULT

• 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.

  PMID: 35425983 RESULT

Related Links

• ESPOIR Website

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Axel Haverich, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

• Samir Sarikouch, PD Dr.

  Hannover Medical School

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: January 14, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: April 29, 2022

Record last verified: 2022-04

Locations

GB (1); MO (1); CH (1); DE (1); BE (1); FR (1); IT (1); NL (1)