A Study of the Effectiveness of the Melody Transcatheter Pulmonary Valve in Patients with a Dysfunctional Bioprosthetic Valve.

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 15-007347
    Sponsor Protocol Number: 15-007347

About this study

The purpose of this study is to evaluate the safety and effectiveness of the Melody Transcatheter Pulmonary Valve used in patients with a dysfunctional bioprosthetic valve.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Previous implantation of a Melody Transcatheter Pulmonary Valve in the pulmonary position within a dysfunctional stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that was expanded to no greater than 22mm at time of implant

Exclusion Criteria

  • Previous or current participation in a Medtronic-sponsored Melody TPV study
  • Implantation of the Melody TPV within a dysfunctional BPV in the aortic, mitral, or tricuspid position

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Allison Cabalka, M.D.

Closed for enrollment

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CLS-20192075

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