Melody® Transcatheter Pulmonary Valve Post-Approval Study

Completed · Not applicable

Conditions studied: Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

In brief

The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.

Key facts

Study ID

NCT01186692

Run by

Medtronic Cardiovascular

People needed

131

Starts

2010-07-01

Expected to finish

2017-10-01

Last updated by the study team

2019-05-01

Who can join

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

You may qualify if…

• Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
• Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)

You may not qualify if…

• Implantation in the aortic 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
• Unwilling or unable to provide written informed consent or comply with the follow-up requirements

Where it is running

• Rady Children's Hospital — San Diego, California, United States
• Advocate Hope Children's Hospital — Oak Lawn, Illinois, United States
• CS Mott Children's Hospital, University of Michigan — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Children's Medical Center Dallas, UT Southwestern — Dallas, Texas, United States
• Primary Children's Medical Center, University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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