Melody PB1016 Surveillance Study

Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits

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 Overview

• Status: Completed
• Conditions: Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects
• Intervention / Treatment: Device: Melody Transcatheter Pulmonary Valve PB1016

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria
    • Landes-Kinderklinik
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Stollery Childrens Hospital
• Spain
  • Madrid, Spain
    • Hospital General Universitario Gregorio Maranon
• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California - Los Angeles
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Childrens Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Primary Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Childrens and Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Melody TPV PB1016	Device: Melody Transcatheter Pulmonary Valve PB1016

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	1 Year, 2 Years
Number of Subjects With Procedural Success	A successful implant is defined as follows: Melody TPV PB1016 is fixated within the desired location; RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is < 35 mmHg; No more than trace/trivial pulmonary regurgitation by angiography; Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant.	At Time Of Procedure
Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016	Kaplan-Meier: Freedom from Stent Fracture; Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016; Kaplan-Meier: Freedom from RVOT Conduit Operation; Kaplan-Meier: Freedom from Death (All-Cause)	2 years

Collaborators and Investigators

• Sponsor: Medtronic Heart Valves

Publications and helpful links

General Publications

• Morray BH, Jones TK, Coe JY, Gitter R, Martinez JZ, Turner DR, Gray RG, Lung TH, Berman DP, Levi DS. Implantation of the Melody transcatheter pulmonary valve PB1016 in patients with dysfunctional right ventricular outflow tract conduits. Catheter Cardiovasc Interv. 2019 Feb 15;93(3):474-480. doi: 10.1002/ccd.27974. Epub 2018 Nov 12.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): August 10, 2018

Study Registration Dates

• First Submitted: September 12, 2014
• First Submitted That Met QC Criteria: January 21, 2015
• First Posted (Estimate): January 27, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: October 22, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 10154745DOC