PERIGON Japan Trial

Not Applicable

Completed

Conditions: Aortic Stenosis

Interventions: Device: 17mm MDT-2215 aortic valve bioprosthesis

Registration Number: NCT02686814

Lead Sponsor: Medtronic Cardiac Surgery

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

Detailed Description: 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.

This clinical trial information was submitted voluntarily under the applicable law and therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act of 42 CRF 11.24 and 11.44.)

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 25

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MDT-2215	17mm MDT-2215 aortic valve bioprosthesis	17mm MDT-2215 aortic valve bioprosthesis

Primary Outcome Measures

Name	Time	Method
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure	This outcome will be identified from measurement at baseline and 1 year.	Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Effective Orifice Area Index at Baseline and 1 Year Post-procedure	This outcome will be measured at 1 year.	Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm\^2/m\^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm\^2, and BSA is the body surface area in m\^2
Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year	This outcome will be identified from measurement at baseline and 1 year.	Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm\^2/m\^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI. See Objective 1 for NYHA definition See Objective 2 for EOAI definition

Secondary Outcome Measures

Name	Time	Method
Cardiac Output (L/Min) From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Safety:Valve-related Adverse Events	This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.	The early (\<=30days post-procedure), late (\>30days post-procedure) and 1-year participant counts 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
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years	This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.	NYHA functional classification evaluation at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. Measure Description: Cardiac Disease with Functional Classes I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years	This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.	Effective orifice area index at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm\^2) per unit body surface area (m\^2). The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2. Effective Orifice Area Index (EOAI) in cm\^2/m\^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm\^2, and BSA is the body surface area in m\^2
Mean Pressure Gradient (mmHg) From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Degree of Transvalvular Regurgitation From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Cardiac Index (L/Min/m^2) From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Degree of Paravalvular Regurgitation From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Degree of Total Valvular Regurgitation From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Performance Index (L/Min) From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Effective Orifice Area (cm^2) From Baseline 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Peak Pressure Gradient (mmHg) From Discharge 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.	This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)	This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.	SF-36 Questionnaire Physical Component Summary (physical functioning, role-physical, bodily pain, general health, vitality) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher physical quality of life. Physical Component Summary Scale Lowest possible score: -7.28 Highest possible score: 52.71
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)	This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.	SF-36 Questionnaire Mental Component Summary (social functioning, role-emotional, mental health) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher quality of mental life. Lowest possible score: 31.63 Highest possible score: 66.69

Trial Locations

Locations (10): Hyogo Prefectural Harima-Himeji General Medical Center
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Hyogo Prefecture, Japan
Chiba-Nishi General Hospital
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Chiba, Japan
University Hospital, Kyoto Prefectural University of Medicine
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Kyoto, Japan
Kurashiki Central Hospital
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Okayama, Japan
Kobe University Hospital
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Hyogo Prefecture, Japan
Saitama Medical Center, Jichi Medical University
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Saitama, Japan
Saitama Medical University International Medical Center
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Saitama, Japan
Sakakibara Heart Institute
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Tokyo, Japan
Tokushima Red Cross Hospital
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Tokushima, Japan
National Cerebral and Cardiovascular Center
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Osaka, Japan