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Melody® Transcatheter Pulmonary Valve Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01186692
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : December 26, 2016
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit Device: Melody® Transcatheter Pulmonary Valve Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
Actual Study Start Date : July 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : October 2017
Arms and Interventions
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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 Name: Melody Transcatheter Pulmonary Valve


Outcome Measures
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Primary Outcome Measures :
  1. Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation [ Time Frame: 6 months ]

    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.



Secondary Outcome Measures :
  1. Procedural Success [ Time Frame: 6 Months ]

    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

  2. Serious Procedural Adverse Events [ Time Frame: 6 Months ]
    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).

  3. Serious Device-related Adverse Events [ Time Frame: 6 months ]
    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).

  4. Changes in NYHA Functional Classification [ Time Frame: 6 Months ]
    Change in NYHA functional class from pre-implant to 6 month post-implant


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:

  • 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
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): NCT01186692


Locations
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United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
United States, Michigan
CS Mott Children's Hospital, University of Michigan
Ann Arbor, Michigan, United States, 48109
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15201
United States, Texas
Children's Medical Center Dallas, UT Southwestern
Dallas, Texas, United States, 75235
United States, Utah
Primary Children's Medical Center, University of Utah
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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Principal Investigator: Jaqueline Kreutzer, MD Children's Hospital of University of Pittsburgh Medical Center
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 Cardiovascular
ClinicalTrials.gov Identifier: NCT01186692    
Other Study ID Numbers: D03909
First Posted: August 23, 2010    Key Record Dates
Results First Posted: December 26, 2016
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided