Harmony TPV Post-Approval Study
Purpose
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.
Conditions
- Congenital Heart Disease
- Tetrology of Fallot
- RVOT Anomaly
- Pulmonary Regurgitation
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Obstruction of the central veins - Planned concomitant branch pulmonary artery stenting at time of implant - Subject is pregnant at time of implant procedure - Patients with previously treated with an RV-PA conduit or previously implanted bioprosthesis - A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year - Planned implantation of the Harmony TPV in the left heart - Echocardiographic evidence of intracardiac mass, thrombus, or vegetation - Pre-existing prosthetic heart valve or prosthetic ring in any position
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Harmony TPV System |
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery System |
|
Recruiting Locations
University of Alabama at Birmingham Hospital
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Contact:
Mark Law, MD
Mark Law, MD
More Details
- Status
- Recruiting
- Sponsor
- Medtronic Cardiovascular