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OpenTrials
Completed

NCT Number: NCT01186692

Melody® Transcatheter Pulmonary Valve Post-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.

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Key information

Conditions

Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduit

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rady Children's Hospital, San Diego, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Melody® Transcatheter Pulmonary Valve

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiovascular

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
Study completion
2017
First posted
Aug 23, 2010
Registry last updated
May 1, 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.