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

Overview

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

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

Clinical Trials