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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 20
- 主要终点
- Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the 17mm MDT-2215 aortic valve bioprosthesis.
详细描述
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)