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Pulmonic Valve REplacement Multi-discIpline EMEA Registry

NCT01356108 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2018-11-20

No results posted yet for this study

Summary

The purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available Edwards SAPIEN Valve with the RF3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

Conditions

  • Pulmonary Regurgitation
  • Pulmonary Insufficiency
  • Pulmonary Stenosis

Interventions

DEVICE

Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)

The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Peter Ewert, MD · Deutsches Herzzentrum München

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-07-31
Completion
2017-12-19
FDA Device
Yes

Countries

  • Belgium
  • Germany
  • Ireland
  • Israel
  • Italy
  • Poland
  • Saudi Arabia
  • Turkey (Türkiye)
  • 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 NCT01356108 on ClinicalTrials.gov