HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

Study Overview
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Brief Summary
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The purpose of the study is to provide evidence of safety and effectiveness of the study valve. The rationale is to offer a replacement mitral valve for patients with anatomy that is too small for the currently commercially available valves ranging in size from 16mm to 37mm. 20 subjects were enrolled as part of the IDE cohort and an additional 3 were enrolled under continued access.

Detailed Description
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The study is a single arm, prospective, non-randomized, multi-center clinical investigation. The objective of this study is to evaluate the safety and effectiveness of the 15mm MHV in subjects five years or less of age with a diseased, damaged, or malfunctioning mitral heart valve. The objective will be evaluated by assessing valve-related adverse events, subject survival, subject growth, and echocardiogram assessment of hemodynamic function through the five year follow-up visit as long as the valve remains implanted.

Official Title
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HALO Clinical Study: A Single Arm, Prospective, Non-randomized, Multi Center Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve

Conditions
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Mitral Valve Disease, Damaged Mitral Valve, Malfunctioning Mitral Heart Valve, Mitral Valve Replacement

Intervention / Treatment
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* Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve


Participation Criteria
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Eligibility Criteria
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IDE Cohort - Inclusion Criteria: Subject requires mitral valve replacement.* Subject's legally authorized representative gives written consent to participate in the clinical study. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the exclusion criteria. Exclusion Criteria: 1. Subject is > 5 years of age. Subject has a contraindication to anticoagulant/antiplatelet medication. Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.* Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve. Subject has active endocarditis. Subject has active myocarditis. Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure. Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure. Subject has a non-cardiac illness resulting in a life expectancy of < 1 year. Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure. Subject has been previously enrolled and implanted in this study. Subject is participating in another study for an investigational drug and/or device. Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results. Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study. Continued Access Cohort- Prospective Inclusion Criteria: Subject requires mitral valve replacement.* Subject's legally authorized representative gives written consent to participate in the clinical study. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study. Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study. Prospective Exclusion Criteria: Subject is > 5 years of age. Subject has a contraindication to anticoagulant/antiplatelet medication. Retrospective Eligibility Criteria: The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV. An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. The legally authorized representative signs the study informed consent for this protocol allowing access to all relevant historical medical information and prospective follow-up (if applicable). Either the legally authorized representative and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol from the time of consent going forward. OR the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted.

Ages Eligible for Study
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Maximum Age: 5 Years

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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single device arm<br>Mitral valve replacement | Device: Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve<br>* Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint: Kaplan-Meier Percentage of Participants Who Remained Alive or Had Valve Explanted Due to Anatomical Growth | The Kaplan-Meier method is a statistical method that summarizes the rate at which subjects survive or are free from a specified event. The method uses whether or not a subject had the specified event and their time to the specified event or the end of their follow-up to calculate the rate. Kaplan-Meier event rates with 95% confidence intervals would be calculated for overall survival. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months | 
| Primary Effectiveness Endpoint: Peak Gradient as Assessed by Echocardiography | Peak gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months | 
| Primary Effectiveness Endpoint: Mean Gradient as Assessed by Echocardiography | Mean gradient as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months | 
| Primary Effectiveness Endpoint: Number of Participants With Valvular Regurgitation | Valvular regurgitation as assessed by echocardiography at 12 months post implant or when the valve is removed/replaced due to anatomical growth of the subject, whichever occurs first. | 12 months | 
| Primary Safety Endpoint: Rate of Total Valve-related Adverse Events | Kaplan-Meier event rates with 95% confidence intervals would be calculated for valve-related adverse events. All follow-up time through 365 days post implant would be considered. If a subject discontinues prior to one year post implant, all available data would be included. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Change in Height Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data. Summary statistics including number of subjects, mean and standard deviation are provided at the 12-month visit. | 12 months | 
| Percentage Change in Weight Percentiles From Baseline to 12 Months | Percentiles would be summarized by visit interval from baseline to 12 months for all available data.Summary statistics including number of subjects, mean, standard deviation, and difference between visits were used for this endpoint. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral valve