IRB Study Number 22-1150
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters
Inclusion Criteria
- Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
- Patient (or patient’s legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements
Exclusion Criteria
- Anatomy unable to accommodate a 25 Fr delivery catheter system
- Obstruction of the central veins
- Clinical or biological signs of infection including active endocarditis
- Other exclusion criteria will be assessed by study staff
