An Observational Registry on cell-free Allografts (SALAMANDRA)

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Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/40939
• EU PAS number:
  EUPAS28002
• Study ID:
  40939
• Official title and acronym:
  An Observational Registry on cell-free Allografts (SALAMANDRA)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Germany
• Study description:
  Both, acquired and congenital heart disease can require surgical reconstruction or replacement of cardiac valves and/or arteries. Currently available prosthesis materials is not ideal. It may require anticoagulation, with the risk of bleeding, if manufactured from non-organic material, or it may degenerate when derived from animals or human tissue donors. The use of Cell-free Allografts, XFA, may reduce the need for frequent reoperation, especially in children and young adults. The purpose of this investigation is to analyse the performance of XFA 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 XFA. The following outcome variables will be analysed: Primary safety endpoints: Rate of cardiovascular Adverse Reactions, Serious Adverse Reactions, such as infections, immunological reactions. Secondary safety data: Post-operative time until re-operation, re-interventions or death. Primary efficacy endpoint: Rate of freedom from XFA-dysfunction leading to re-intervention or explantation. Secondary efficacy endpoint: Macroscopic changes of XFA after implantation, trans-XFA gradients and XFA-competence, as applicable, assessed by non-invasive imaging tools such as echocardiography.
• Study status:
  Planned

Research institutions and networks

Institutions

Hannover Medical School (MHH)

Cardiothoracic, Transplant, and Vascular Surgery, Hannover Medical School

Germany

UKD Düsseldorf, AKH Wien, Österreich

Study timelines

Date when funding contract was signed

Planned: 01/03/2019

Study start date

Planned: 01/06/2021

Data analysis start date

Planned: 31/12/2030

Date of final study report

Planned: 31/12/2031

Sources of funding

Other

More details on funding

Hannover Medical School HTTG

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable