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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P810002 S101/ PAS001 |
| Date Original Protocol Accepted |
03/06/2018
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| Date Current Protocol Accepted |
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| Study Name |
Cont f/u of the premarket HALO Cohort
|
| Device Name |
SJM Masters Series Mechanical Heart Valve, 15mm HP
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of this study is to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm mitral mechanical heart valve as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning mitral valve.
The study includes continued follow-up of patients enrolled in the HALO study, which was a single arm, prospective, non-randomized, multi-center clinical trial of the SJM™ Masters Series Hemodynamic HP 15mm mitral heart valve.
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| Study Population |
The study population consists of pediatric subjects that are 5 years or less in age with a diseased, damaged, or malfunctioning mitral heart valve.
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| Sample Size |
This study will continue to follow subjects that are alive and in which the valve is still implanted from the following groups:
Subjects enrolled in the HALO study,
Subjects enrolled under Continued Access, and
Emergency/compassionate use subjects who have consented for prospective follow-up.
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| Key Study Endpoints |
The following adverse events (if determined to be valve related and serious) will be summarized annually with descriptive statistics:
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.
The following effectiveness endpoints will be reported at any/all time point(s) available:
Mean gradient as assessed by echocardiography;
Peak gradient as assessed by echocardiography; and
Valvular regurgitation grade as assessed by echocardiography.
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| Follow-up Visits and Length of Follow-up |
Study subjects will be followed annually either for five years from the date of implant, until subject withdrawal, or until end of device use, whichever occurs earliest.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
23 (20 IDE & 3 CAP)
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| Actual Number of Sites Enrolled |
15
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| Patient Follow-up Rate |
The final study follow-up rate at 5 years is 95.6% (22/23)
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| Final Safety Findings |
At 12 months, the K-M freedom from valve-related adverse events was 64.3% for all study subjects. Within 12 months of implant, the following CEC-Adjudicated Valve-related Adverse Events occurred: 6 all-cause deaths, 1 endocarditis, 5 all hemorrhage, 1 nonstructural dysfunction, 5 reoperations, 1 thromboembolism, and 5 thrombus on device. Between 12 months and 5-years, the following additional events occurred: 2 all hemorrhage, 1 nonstructural dysfunction, and 2 reoperations.
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| Final Effect Findings |
Patients showed improvement from baseline in peak and mean valve gradient and valve regurgitation until valve was removed/replaced due to anatomical growth.
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| Study Strengths & Weaknesses |
One strength of the study was that it had a high follow-up rate (95.6%) with only 1 patient lost to follow-up. A weakness of the study is that it is a single arm study with a smaller sample size.
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| Recommendations for Labeling Changes |
Updates to the labeling are recommended
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