Melody® Transcatheter Pulmonary Valve Post-Approval Study

Medtronic Cardiovascular131 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

Interventions

Melody® Transcatheter Pulmonary ValveDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (10)

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

Outcomes

Primary Outcomes

Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation

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.

Time frame: 6 months

Secondary Outcomes

Procedural Success

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

Time frame: 6 Months

Serious Procedural Adverse Events

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).

Time frame: 6 Months

Serious Device-related Adverse Events

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).

Time frame: 6 months

Changes in NYHA Functional Classification

Change in NYHA functional class from pre-implant to 6 month post-implant

Data from ClinicalTrials.gov

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