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Pulmonic SAPIEN XT THV

NCT02302131 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 49

Last updated 2017-04-05

No results posted yet for this study

Summary

Multi-center, Observational Registry with Retrospective Enrollment and Prospective Follow-up.

The aim of the registry is to document the feasibility and safety of implanting an Edwards SAPIEN XT transcatheter heart valve in the pulmonic position.

Conditions

  • Pulmonary Valve Malfunction

Interventions

OTHER

SAPIEN XT

Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection

Sponsors & Collaborators

  • Estimate, GmbH

    collaborator INDUSTRY

  • Institut für Pharmakologie und Präventive Medizin

    lead NETWORK

Principal Investigators

  • Nikolaus Haas, MD · Center for Congenital Heart Defects, Heart and Diabetes Center NRW

  • Peter Bramlage, MD · IPPMed

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2017-04-30

Countries

  • Belgium
  • Canada
  • Switzerland

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 NCT02302131 on ClinicalTrials.gov