Melody® Transcatheter Pulmonary Valve Post-Approval Study

Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study

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 Overview

• Status: Completed
• Conditions: Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit
• Intervention / Treatment: Device: Melody® Transcatheter Pulmonary Valve

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Rady Children's Hospital
  • Illinois
    • Oak Lawn, Illinois, United States, 60453
      • Advocate Hope Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • CS Mott Children's Hospital, University of Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia
    • Pittsburgh, Pennsylvania, United States, 15201
      • Children's Hospital of Pittsburgh of UPMC
  • Texas
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas, UT Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center, University of Utah

Participation Criteria

Eligibility Criteria

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

Description

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

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
Experimental: Melody TPV Implant; Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.	Device: Melody® Transcatheter Pulmonary Valve; 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.; Other Names: Melody Transcatheter Pulmonary Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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).	6 months
Changes in NYHA Functional Classification	Change in NYHA functional class from pre-implant to 6 month post-implant	6 Months

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Investigators: Principal Investigator: Jaqueline Kreutzer, MD, Children's Hospital of University of Pittsburgh Medical Center

Publications and helpful links

General Publications

• Armstrong AK, Berger F, Jones TK, Moore JW, Benson LN, Cheatham JP, Turner DR, Rhodes JF, Vincent JA, Zellers T, Lung TH, Eicken A, McElhinney DB. Association between patient age at implant and outcomes after transcatheter pulmonary valve replacement in the multicenter Melody valve trials. Catheter Cardiovasc Interv. 2019 Oct 1;94(4):607-617. doi: 10.1002/ccd.28454. Epub 2019 Aug 16.
• McElhinney DB, Benson LN, Eicken A, Kreutzer J, Padera RF, Zahn EM. Infective endocarditis after transcatheter pulmonary valve replacement using the Melody valve: combined results of 3 prospective North American and European studies. Circ Cardiovasc Interv. 2013 Jun;6(3):292-300. doi: 10.1161/CIRCINTERVENTIONS.112.000087. Epub 2013 Jun 4.
• Armstrong AK, Balzer DT, Cabalka AK, Gray RG, Javois AJ, Moore JW, Rome JJ, Turner DR, Zellers TM, Kreutzer J. One-year follow-up of the Melody transcatheter pulmonary valve multicenter post-approval study. JACC Cardiovasc Interv. 2014 Nov;7(11):1254-62. doi: 10.1016/j.jcin.2014.08.002. Epub 2014 Nov 17.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: D03909

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided