Melody PB1016 Surveillance Study

Completed · Not applicable

Conditions studied: Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

In brief

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.

Key facts

Study ID

NCT02347189

Run by

Medtronic Heart Valves

People needed

39

Starts

2014-11-01

Expected to finish

2018-08-10

Last updated by the study team

2019-11-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
• Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

You may not qualify if…

• Implantation in the aortic, tricuspid, or mitral position
• Venous anatomy unable to accommodate a 22-Fr size introducer sheath
• Obstruction of the central veins
• Clinical or biological signs of infection including active endocarditis
• History of intravenous substance abuse
• Currently participating in an investigational drug or device study

Where it is running

• University of California - Los Angeles — Los Angeles, California, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Nationwide Childrens Hospital — Columbus, Ohio, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Seattle Childrens and Regional Hospital — Seattle, Washington, United States
• Landes-Kinderklinik — Linz, Austria
• Stollery Childrens Hospital — Edmonton, Alberta, Canada
• Hospital General Universitario Gregorio Marañón — Madrid, Spain

Full record on ClinicalTrials.gov

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