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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P200046 / PAS001 |
| Date Original Protocol Accepted |
03/26/2021
|
| Date Current Protocol Accepted |
11/03/2023
|
| Study Name |
Continued Follow-up of the Harmony TPV IDE Cohort
|
| 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 |
Continued follow-up of all patients enrolled under IDE G120175, including the Continued Access Protocol investigation patients. The objective of the study is to characterize the clinical outcomes annually, unless otherwise specified, through 10 years post implant.
|
| Study Population |
All patients enrolled under IDE G120175, including the Continued Access Protocol investigation patients.
|
| Sample Size |
82
|
| Key Study Endpoints |
Device success, freedom from TPV dysfunction, freedom from all-cause mortality, serious device-related adverse events, quality of life score (SF-36; 6 months, 2 years, 5 years and 10 years), and reoperation.
|
| Follow-up Visits and Length of Follow-up |
10 years
|
| Interim or Final Data Summary |
| Interim Results |
One-hundred and six subjects were successfully implanted with the device in the Harmony TPV and Native studies. Two subjects had the device explanted immediately post-implant. There have been 0 deaths due to device or procedure. Kaplan-Meier Freedom from all-cause mortality in all subjects is 97% at 24 months. Kaplan Meier Freedom from reoperation in all subjects is 96.2% at 24 months.
The most frequent CEC adjudicated procedure-related serious adverse events are: minor hemorrhage: 6.5% (7); Other vascular access site complication: 2.8% (3); Embolization of the TPV: 1.9% (2); Migration of the TPV: 1.9% (2); and minor Paravalvular leak: 1.9% (2).
The most frequent CEC adjudicated device-related serious adverse events are: ventricular tachycardia: 17.8% (19); ventricular premature beats: 8.4% (9); minor paravalvular leak: 5.6% (6); and valve stenosis: 4.7% (5).
|
| Actual Number of Patients Enrolled |
420 subjects were enrolled, 87 were catheterized and 86 have been implanted (Harmony TPV study); 66 subjects were enrolled, 21 subjects were catheterized and 20 subjects were implanted (Native TPV Study).
|
| Actual Number of Sites Enrolled |
10
|
| Patient Follow-up Rate |
Eighty-four patients reached the 1-year follow-up window and follow-up was complete for 81 (96.4%) patients (Harmony TPV study).
|
| Final Effect Findings |
88.3% (91 subjects) have Acceptable TPV Hemodynamic Function and without valve re-intervention at 6 months. Key measurements of Right Ventricular Remodeling Following TPV Implant such as RVEDV, LVEDV, PRF%, and Net Right ventricular Stroke Volume have improved at 6-months from baseline and continue to improve through 2 years.
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