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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P810002 S101/ PAS002 |
| Date Original Protocol Accepted |
12/07/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
HALO PAS
|
| Device Name |
SJM Masters Series Mechanical Heart Valve, 15mm HP
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This PAS is an observational single arm, non-randomized, multi-center clinical trial. Data from patients prospectively and retrospectively enrolled may contribute to the study dataset as follows:
Enrollment of new, prospective patients receiving a 15 AHPJ-505 MHV in the aortic position;
Enrollment of patients previously implanted with a 15AHPJ-505 MHV in the aortic position consenting for retrospective inclusion
|
| Study Population |
Patients requiring aortic valve replacement with anatomy that requires a 15mm valve (< 18 years old)
|
| Sample Size |
No. of subjects:
A minimum of 20 subjects implanted with the 15mm HP aortic valve (echocardiography data reported whenever it is available); or
A minimum of 12 subjects with echocardiography data at a time point(s) greater than 90 days
No. of sites: 40 sites across US and 10 sites outside of the US
|
| Key Study Endpoints |
Safety Endpoints
Primary:
The actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced (whether or not the replacement or removal is due to anatomical growth of the subject), whichever occurs first. Valve-related adverse events to be evaluated are:
- Death;
- Endocarditis;
- Hemorrhage (whether or not due to anticoagulant/antiplatelet medication);
- Nonstructural dysfunction (including perivalvular leak, hemolysis, and hemolytic anemia);
- Reoperation (including valve explant, not due to anatomical growth of the subject);
- Structural valve deterioration;
- Thromboembolism; and
- Valvular thrombosis.
Secondary:
-All-cause mortality
-Valve-related mortality
-Reoperation or explant excluding replacement due to somatic growth
Effectiveness Endpoints:
Primary:
- Peak gradient as assessed by echocardiography;
- Mean gradient as assessed by echocardiography;
- Valvular regurgitation type (central or perivalvular) and grade as assessed by echocardiography.
|
| Follow-up Visits and Length of Follow-up |
Frequency: Baseline, procedure, post procedure, 30D, 6mo, 1 year and annually thereafter
Length: 5 years or explant
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