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Melody Transcatheter Pulmonary Valve Study: Post Approval Study of the Investigational Device Exemption Cohort

NCT00740870 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2024-03-26

Study results available
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Summary

The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.

Conditions

  • Congenital Heart Defects
  • Dysfunctional Right Ventricular Outflow Tract Conduits

Interventions

DEVICE

Transcatheter Pulmonary Valve replacement

Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.

Sponsors & Collaborators

  • Medtronic Cardiovascular

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2015-05-31
Completion
2020-08-21

Countries

  • United States

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 NCT00740870 on ClinicalTrials.gov