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Melody PB1016 Surveillance Study

NCT02347189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2019-11-06

Study results available
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Summary

Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.

Conditions

  • Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Interventions

DEVICE

Melody Transcatheter Pulmonary Valve PB1016

Sponsors & Collaborators

  • Medtronic Heart Valves

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-11-30
Completion
2018-08-10

Countries

  • United States
  • Austria
  • Canada
  • Spain

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 NCT02347189 on ClinicalTrials.gov