Melody® Transcatheter Pulmonary Valve Post-Approval Study

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Melody TPV Implant	Melody® Transcatheter Pulmonary Valve	Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.

Primary Outcome Measures

Name	Time	Method
Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation	6 months	Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.

Secondary Outcome Measures

Name	Time	Method
Serious Device-related Adverse Events	6 months	A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Changes in NYHA Functional Classification	6 Months	Change in NYHA functional class from pre-implant to 6 month post-implant
Procedural Success	6 Months	Procedural success is defined as a composite of the following: * The TPV is fixated within the desired location, and * The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and * There is no more than trivial pulmonary regurgitation by angiography * The subject is free from explantation of the TPV at 24 hours post-implant
Serious Procedural Adverse Events	6 Months	A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).

Locations (10): Rady Children's Hospital
🇺🇸
San Diego, California, United States
Advocate Hope Children's Hospital
🇺🇸
Oak Lawn, Illinois, United States
Children's Hospital of Pittsburgh of UPMC
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Pittsburgh, Pennsylvania, United States
Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas, UT Southwestern
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Dallas, Texas, United States
Primary Children's Medical Center, University of Utah
🇺🇸
Salt Lake City, Utah, 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
🇺🇸
Saint Louis, Missouri, United States