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Completed

NCT Number: NCT02035540

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

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Key information

Conditions

Heart Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Leuven, UZL, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®.

Treatment and study plan

Decellularized human valves

Other

Other names: ESPOIR PV

Primary outcomes

  1. Amount of SARs (serious adverse reactions)

    Time frame: up to 24 months

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

  2. Freedom from valve dysfunction

    Time frame: up to 24 months

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

Secondary outcomes

  1. Blood Parameters

    Time frame: up to 24 months

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

  2. Diameters of ESPOIR PV at end of the study

    Time frame: after 24 months

    Diameters of ESPOIR PV at end of the study in comparison to diameters at implantation

  3. Time to reoperation

    Time frame: up to to 24 months

    Time to reoperation due to explantation

  4. Time to death

    Time frame: up to 24 months

    Time to death

  5. Evaluation of transvalvular gradients

    Time frame: up to 24 months

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

Sponsors and collaborators

Lead sponsor

corlife

Industry

Collaborators

  • 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 KU Leuven
  • University of Padova
  • University of Zurich

Registry information

Acronym: ESPOIR

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 14, 2014
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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