A Study of the Effectiveness of the Melody Transcatheter Pulmonary Valve in Patients with a Dysfunctional Bioprosthetic Valve.
Overview
Tab Title Description
Study type
ObservationalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Allison Cabalka, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available