NCT00740870

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

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 is 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

Type	Name	Description
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.

Timeline

• Start date: 2007-01-01
• Primary completion: 2015-05-01
• Completion: 2020-08-21
• First posted: 2008-08-25
• Last updated: 2024-03-26
• Results posted: 2017-07-02

Locations

5 sites across 1 country: United States