European Clinical Study for the Application of Regenerative Heart Valves – ESPOIR (the “Surveillance”)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Single-arm clinical Surveillance

Study drug and medical condition

• Medicinal product name, other:
  decellularized human pulmonary valve, Espoir PV

Population studied

• Short description of the study population:
  Inclusion Criteria; The following inclusion criteria will be used in this Surveillance:; 1. Indication for pulmonary valve replacement according to current medical guidelines in heart disease; 2. Informed consent of legal guardians or patients, assent of patients; ; Exclusion Criteria; 1. The patient has not provided Surveillance informed consent.; 2. The patient shall not suffer from; a. generalized connective tissue dis-orders (eg, Marfan syndrome), or; b. active rheumatic disorders, or; c. severe asymmetric calcification of the valve ring.; 3. The coronary arteries of the patient shall not be in abnormal position or heavily calcified.; 4. Patients shall not show hypersensitivity against sodium dodecyl sulphate (SDS), sodium desoxycholate (SDC), human collagen (or other elastic fibers) or Benzonase®
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  Purpose of this investigation is to evaluate decellularized human pulmonary valve, Espoir PV for pulmonary valve replacement rates in comparison to current valve substitutes within a prospective multicentre surveillance at 8 leading European Centres for Congenital Cardiothoracic Surgery regarding re-operation and re-intervention, hemodynamic performance, growth potential and long-term durability.
• Outcomes:
  Safety: Rate of cardiovascular adverse reactions, leading to e.g. re-operation, catheter based interventions.Efficacy: Freedom from valve dysfunction leading to re-intervention or explanation at end of the Surveillance. Safety: Collection of medical data to assess the process of tissue vigilance. Collection of medical history to support the presence/absence of adverse events, e.g. infections, arrhythmia.Efficacy: Diameters of ESPOIR PV at end of the Surveillance in comparison to diameters at implantation, transvalvular gradients, valve competence assessed by non-invasive imaging tools (echocardiography or MRI).
• Data analysis plan:
  Actuarial analysis according to Kaplan-Meier will be used to show estimated probability of freedom from each AR. Actuarial analysis takes into account both early and late post-operative events. The time from ESPOIR PV implantation to endpoint ESPOIR PV dysfunction that requires either a catheter-based or a surgical procedure will also be calculated according Kaplan and Meier.Patient baseline risk will be statistically compared between all participating centres (Statistics to be provided by the Surveillance Statistician). Chi-square tests will be used to compare categorical risk factors while analysis of variance will be used to compare continuous risk factors. Comparisons will be based on the following demographic and pre-operative variables: age, sex, underlying congenital heart defect, previous (heart valve replacement) surgery, valvular lesion, pre-operative NYHA, concomitant cardiac procedures, and coexisting cardiovascular conditions as well as the size of implanted valves.