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

N/ACompletedNCT02035540

corlife121 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

121

Conditions

Heart Valve Disease

Interventions

Decellularized human valvesOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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®.

Locations (8)

Universitair Ziekenhuis Leuven, UZL

Leuven, Belgium

Université Paris Descartes, UPD

Paris, France

Hannover Medical School

Hanover, Germany

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

Padova, Italy

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

Chisinau, Moldova

Leids Universitair Medisch Centrum, LUMC

Leiden, Netherlands

Universitaet Zuerich, UZH, Switzerland

Zurich, Switzerland

Great Ormond Street Hospital for Children NHS Trust, GOSH

London, United Kingdom

Outcomes

Primary Outcomes

Amount of SARs (serious adverse reactions)

Cardiovascular Adverse Reactions; Serious Adverse Reactions, such as infections, immunological reactions, etc.

Time frame: up to 24 months

Freedom from valve dysfunction

Freedom from valve dysfunction leading to re-intervention or explantation at end of the study.

Time frame: up to 24 months

Secondary Outcomes

Blood Parameters

Blood Parameters as additional safety data to support presence/absence of Adverse Reactions

Time frame: 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

Time frame: after 24 months

Time to reoperation

Time to reoperation due to explantation

Time frame: up to to 24 months

Time to death

Time frame: up to 24 months

Evaluation of transvalvular gradients

valve competence assessed by noninvasive imaging tools such as echocardiography or cardiac magnetic resonance imaging

Time frame: up to 24 months