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Completed

NCT Number: NCT02347189

Melody PB1016 Surveillance Study

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.

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Key information

Conditions

Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landes-Kinderklinik, Linz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Melody Transcatheter Pulmonary Valve PB1016

Device

Primary outcomes

  1. Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months

    Time frame: 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

Secondary outcomes

  1. Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year

    Time frame: 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.

  2. Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years

    Time frame: 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.

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

    Time frame: 1 Year, 2 Years

    • 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

  4. Number of Subjects With Procedural Success

    Time frame: At Time Of Procedure

    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.

  5. Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016

    Time frame: 2 years

    • 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)

Sponsors and collaborators

Lead sponsor

Medtronic Heart Valves

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
Jan 27, 2015
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.