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Aortic Replacement Using Individualised Regenerative Allografts - ARISE (the "Surveillance")

NCT02527629 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 144

Last updated 2020-06-02

No results posted yet for this study

Summary

Evaluation of decellularized human heart valves for aortic 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.

Conditions

  • Heart Valve Disease

Interventions

OTHER

Decellularized human heart valves

Decellularized human aortic heart valves

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • Leiden University Medical Center

    collaborator OTHER

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Royal Brompton & Harefield NHS Foundation Trust

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER

  • Vienna General Hospital

    collaborator OTHER

  • corlife

    lead INDUSTRY

Principal Investigators

  • Axel Haverich, Prof. Dr. · Hannover Medical School

  • Samir Sarikouch, PD Dr. · Hannover Medical School

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-01-31
Completion
2019-03-31

Countries

  • Belgium
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02527629 on ClinicalTrials.gov