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Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

NCT00688571 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2015-10-29

No results posted yet for this study

Summary

This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.

Conditions

  • Heart Valve Diseases

Interventions

DEVICE

Melody Transcatheter Pulmonary Valve

Transcatheter valve implantation into a RV-PA conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs intervention

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • John Hess, Prof. · Deutsches Herzzentrum München

  • Felix Berger, Prof. · German Heart Institute

  • Lars Soendergaard, Dr. · Rigshospitalet, Denmark

  • Maria Giulia Gagliardi, Dr. · Ospedale Bambino Gesu Rome

  • Jose Suarez de Lezo, Dr. · Hospital Reina Sofia Cordoba

  • Lee Benson, Dr. · The Hospital for Sick Children

  • Maarten Witsenburg, Dr. · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada
  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT00688571 on ClinicalTrials.gov