Melody PB1016 Surveillance Study

Medtronic Heart Valves39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Interventions

Melody Transcatheter Pulmonary Valve PB1016DEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Locations (8)

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

Outcomes

Primary Outcomes

Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months

Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation

Time frame: 6 Months

Secondary Outcomes

Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year

Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation.

Time frame: 1 Year

Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years

Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation.

Time frame: 2 Years

Number of Subjects With Serious Procedure-related and Device-related Adverse Events

* Serious procedure-related adverse events at 1year and 2 years post-implant * Serious device-related adverse events at 1 year and 2 years post-implant

Time frame: 1 Year, 2 Years

Number of Subjects With Procedural Success

Data from ClinicalTrials.gov

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