An Observational Registry on cell-free Allografts (SALAMANDRA)

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Registry study

Study drug and medical condition

• Name of medicine, other:
  cellfree human pulmonary valveEspoir PV, cellfree human aortic valve Arise AV, cellfree human truncus pulmonalis, Espoir TP, cellfree human Aorta, Arise AT

Population studied

• 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)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  The purpose of this investigation is to analyse the performance of cell-free allografts for cardiovascular reconstruction, such as valve replacement, regarding re-operation and re-intervention, hemodynamic performance and long term durability.This will be an observational registry study of isolated or combined procedures using cell-free allografts.
• Outcomes:
  Safety:Rate of cardiovascular Adverse Reactions, Serious Adverse Reactions, such as infections, immunological reactions.Efficacy:Rate of freedom from cell-free allograft dysfunction leading to re-intervention or explantation. Safety:Post-operative time until re-operation, re-interventions or deathEfficacy:Macroscopic changes of cell-free allografts after implantation, trans-cell-free allograft gradients and cell-free allograft-competence, as applicable, assessed by non-invasive imaging tools such as echocardiography.
• 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 postoperative events.The time from cell-free allograft implantation to endpoint dysfunction that requires either a catheter-based or a surgical procedure will be calculated according Kaplan-Meier.Patient baseline risk will be statistically compared between all participating centres. Statistics will be provided by the registry 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 heart defect, previous cardiac surgeries, cardiac lesions, pre-operative NYHA, concomitant cardiac procedures, and coexisting cardiovascular conditions. Also included in the analysis will be the size of implanted cell-free allograft.