NCT00688571

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

Melody TPV Post-Market Surveillance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2007-10-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2008-06-03
• Last updated: 2015-10-29

Locations

7 sites across 6 countries: Canada, Denmark, Germany, Italy, Netherlands, Spain