PERIGON Japan Trial

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.

Detailed Description
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This is a prospective, interventional, non-randomized, multi-center trial, with each site following a common protocol in Japan. A maximum of 20 subjects will be implanted at a maximum of 10 sites in Japan. The trial will include male and female patients of legal age to provide informed consent in Japan, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Patients will be followed and assessed after implant for up to 5 years.

Official Title
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A Multi-center, Non-randomized Trial to Determine the Safety and Effectiveness of the 17mm MDT-2215 Aortic Valve Bioprosthesis in Patients With Aortic Valve Disease

Conditions
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Aortic Stenosis

Intervention / Treatment
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* Device: 17mm MDT-2215 aortic valve bioprosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has severe aortic stenosis or regurgitation, and there is clinical indication for replacement of their native or prosthetic aortic valve with a bioprosthesis, with or without concomitant procedures, which are limited to any of the following: Left atrial appendage (LAA) ligation Coronary artery bypass graft (CABG) Patent foramen ovale (PFO) closure Ascending aortic aneurysm or dissection repair not requiring circulatory arrest Resection of a sub-aortic membrane not requiring myectomy Patient is geographically stable and willing to return to the implanting site for all follow-up visits Patient is of legal age to provide informed consent Patient has been adequately informed of risks and requirements of the trial and is willing and able to provide informed consent for participation in the clinical trial In the opinion of the investigator, pre-operative imaging indicates the patient may be suitable for a 17mm size valve Exclusion Criteria: Patient has a pre-existing prosthetic valve or annuloplasty device in another position or requires replacement or repair of the mitral, pulmonary or tricuspid valve Patient has had previous implant and then explant of the MDT-2215 aortic valve bioprosthesis Patient presents with active endocarditis, active myocarditis or other systemic infection Patient has an anatomical abnormality which would increase surgical risk of morbidity or mortality, including: Ascending aortic aneurysm or dissection repair requiring circulatory arrest Acute type A aortic dissection Ventricular aneurysm Porcelain aorta Hostile mediastinum Hypertrophic obstructive cardiomyopathy (HOCM) Documented pulmonary hypertension (systolic >60mmHg) Patient has a non-cardiac major or progressive disease, with a life expectancy of less than 2 years. These conditions include, but are not limited to: Child-Pugh Class C liver disease Terminal cancer End-stage lung disease Patient has renal failure, defined as dialysis therapy or glomerular filtration rate (GFR)<30 mL/min/1.73 m2 Patient has hyperparathyroidism Patient is participating in another investigational device or drug trial or observational competitive study Patient is pregnant, lactating or planning to become pregnant Patient has a documented history of substance (drug or alcohol) abuse Patient has greater than mild mitral valve regurgitation or greater than mild tricuspid valve regurgitation as assessed by echocardiography Patient has systolic ejection fraction (EF)<20% as assessed by echocardiography Patient has grade IV diastolic dysfunction Patient has documented bleeding diatheses Patient has had an acute preoperative neurological deficit or myocardial infarction and has not returned to baseline or stabilized ≥30 days prior to enrollment Patient requires emergency surgery Patient is in NYHA Class I Operative Exclusion Criteria: 1.) Prior to attempted implant of MDT-2215 valve, it is identified the patient requires a concomitant procedure not allow per the enrollment exclusion criteria 2.) Patient anatomy is not suitable for implant of a size 17mm MDT-2215 aortic valve bioprosthesis
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 |
| --- | --- |
| Experimental: MDT-2215<br>17mm MDT-2215 aortic valve bioprosthesis | Device: 17mm MDT-2215 aortic valve bioprosthesis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in NYHA classification from baseline to 1 year post-procedure | Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. | This outcome will be measured at 1 year. | 
| Change in the effective orifice area index from baseline to 1 year post-procedure | Change in effective orifice area index from baseline to 1 year post-procedure will be evaluated. | This outcome will be measured at 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of NYHA functional classification | NYHA functional classification evaluation at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Evaluation of effective orifice area index (cm2/m2) | Effective orifice area index at discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm2) per unit body surface area (m2). | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Effective orifice area (cm2) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Peak pressure gradient (mmHg) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Mean pressure gradient (mmHg) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Degree of valvular regurgitation (transvalvular, paravalvular, and total) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Performance index (unitless) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Cardiac output (L/min) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Cardiac index (L/min/m2) | This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory. | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Safety:Valve-related adverse event rates | The early (<=30days post-procedure), late (>30days post-procedure) and 1-year incidence rates of the following valve-related adverse events will be evaluated: thromboembolism thrombosis hemorrhage paravalvular leak endocarditis hemolysis structural valve deterioration non-structural dysfunction reintervention explant death | This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. | 
| Quality of Life Assessment | SF-36 Questionnaire at 3-6 months, 1 year and annually thereafter through 5 years | This outcome will be evaluated at 3-6 months, 1 year and annually thereafter up to 5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Valvular heart disease, Severe aortic stenosis, Aortic valve replacement