Congenital Heart Disease, Pulmonary Regurgitation, RVOT Anomaly, Tetrology of Fallot
Conditions
Brief summary
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.
Interventions
DEVICEHarmony TPV System
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: | 6 months | * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects free from all-cause mortality at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Percentage of subjects free from reoperation at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Percentage of subjects free from catheter reintervention at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Percentage of subjects free from TPV dysfunction at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Number and percentage of subjects with procedure success at 30-days | 30-days | — |
| Number and percentage of subjects with serious device-related adverse events at 6 months | 6 months | Also described with Kaplan-Meier method for AEs of clinical interest. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORDavid Balzer, MD
St. Louis Children's Hospital
Outcome results
None listed