|
General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P200046 / PAS002 |
Date Original Protocol Accepted |
03/26/2021
|
Date Current Protocol Accepted |
03/22/2024
|
Study Name |
Harmony TPV New Enrollment Study
|
Device Name |
Harmony™ TPV System
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
A prospective, single-arm, multi-center study. The objective of the study is to characterize the real-world performance of the Harmony TPV through 10 years post implant.
|
Study Population |
Patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction greater than or equal to 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.
|
Sample Size |
150
|
Key Study Endpoints |
Proportion of patients without valve intervention and with acceptable hemodynamic function at 6 months, procedure success at 30 days, as well as freedom from all-cause mortality, freedom from reoperation, freedom from catheter reintervention, freedom from TPV dysfunction, and serious procedure- and device-related adverse events at 6 months and annually through 10 years.
|
Follow-up Visits and Length of Follow-up |
10 years
|
Interim or Final Data Summary |
Interim Results |
N/A - Adverse Events: There has been no site reported adverse events, device deficiencies, surgical or catheter reinterventions reported for the study as of the data cutoff date.
|
Actual Number of Patients Enrolled |
5 subjects enrolled, 2 implanted
|
Actual Number of Sites Enrolled |
5
|
Patient Follow-up Rate |
N/A – first patient was implanted on October 27, 2021; therefore, no patients have reached 6-month follow-up yet.
|
Final Effect Findings |
N/A – 2 patients have been implanted and 0 have reached 6-month follow-up.
|