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Melody PB1016 Surveillance Study

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ClinicalTrials.gov Identifier: NCT02347189
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : November 29, 2017
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Heart Valves )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysfunctional RVOT Conduits in Patients With Congenital Heart Defects Device: Melody Transcatheter Pulmonary Valve PB1016 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : August 10, 2018
Arms and Interventions
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Arm Intervention/treatment
Melody TPV PB1016 Device: Melody Transcatheter Pulmonary Valve PB1016


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347189


Locations
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United States, California
University of California - Los Angeles
Los Angeles, California, United States, 90095
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Ohio
Nationwide Childrens Hospital
Columbus, Ohio, United States, 43205
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84132
United States, Washington
Seattle Childrens and Regional Hospital
Seattle, Washington, United States, 98105
Austria
Landes-Kinderklinik
Linz, Austria
Canada, Alberta
Stollery Childrens Hospital
Edmonton, Alberta, Canada, T6G 2B7
Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Sponsors and Collaborators
Medtronic Heart Valves
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Heart Valves
ClinicalTrials.gov Identifier: NCT02347189    
Other Study ID Numbers: 10154745DOC
First Posted: January 27, 2015    Key Record Dates
Results First Posted: November 29, 2017
Last Update Posted: November 6, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities