SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

Study Overview
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Brief Summary
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This PAS is an observational, non-randomized, multi-center, single arm, clinical study to evaluate long term safety and effectiveness of the SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve (15 AHPJ-505) as a replacement device for pediatric patients with a diseased, damaged, or malfunctioning aortic valve.

Official Title
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A Single Arm, Non-randomized, Multi-center Clinical Study of the SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: Aortic Valve Replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion criteria for prospectively enrolled subjects Subject's legal guardian must provide written informed consent prior to any clinical study related procedure. Subject requires aortic valve replacement and is intended to be implanted with a 15mm SJM15 AHPJ-505 MHV as determined by the implanting physician in accordance with the Instructions for Use. The legal guardian and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol for the duration of the clinical study. Inclusion criteria for retrospectively enrolled subjects : In an effort to ensure data on all real-world use conditions are consistently collected and reported on, a subject is eligible to participate in this post-approval study if he/she meets all of the following inclusion criteria and meets no exclusion criterion. For those subjects with a previous implant attempt to be eligible for study participation, the following inclusion criteria must be met: Echocardiography data at a time point greater than 90 days is available or may be acquired. An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. Either: For living subjects who already received the 15mm MHV, the legal guardian signs the study informed consent for this protocol allowing access to all relevant historical medical information, and complete all required assessments according to this protocol from the time of consent going forward (if applicable). OR For subjects who are deceased or explanted, an implantation with 15mm MHV was attempted and the subject's legal guardian provides written informed consent for retrospective data collection of patient and study valve related information through death or explant of the study device. Exclusion Criteria: Exclusion criteria for prospectively enrolled subjects: Subject has a contraindication to anticoagulant/antiplatelet medication. Exclusion criteria of retrospectively enrolled subjects: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single Arm<br>Surgical treatment of a diseased, damaged, or malfunctioning aortic valve using SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve surgical replacement device | Device: Aortic Valve Replacement<br>* SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve as a replacement device for patients with a diseased, damaged, or malfunctioning aortic valve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of total serious valve-related adverse events | actuarial (Kaplan-Meier) rate of total serious valve-related adverse events experienced through 5 years post implant or until the valve is removed/replaced. 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 Valvular thrombosis | 5 Years | 
| Peak gradient as assessed by echocardiography | Peak gradient as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year | Up to 5 years | 
| Mean gradient as assessed by echocardiography | Mean gradient as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year | Up to 5 years | 
| Valvular regurgitation as assessed by echocardiography | Valvular regurgitation as assessed by echocardiography at 30 Days, 6 Months, 1 Year, 2 Year, 3 Year, 4 Year, 5 Year | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all-cause deaths |  | 1 Year | 
| Number of valve-related deaths |  | 1 Year | 
| Number of reoperations or explants excluding replacement due to somatic growth |  | 1 Year |