Clinical Evaluation of the Size 23mm Carpentier-Edwards PERIMOUNT Magna Mitral Bioprosthesis, Model 7000TFX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Percent of Late Adverse Events
研究概览
简要总结
The purpose of this clinical study is to obtain human clinical data that demonstrates that the size 23mm Carpentier-Edwards PERIMOUNT Magna mitral pericardial valve, model 7000TFX, is a safe and effective replacement heart valve.
详细描述
This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational sites within the US and internationally.
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
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has mitral valve disease requiring surgical replacement
- •Patient has provided written informed consent prior to mitral valve surgery
- •Patient is expected to survive surgery and be discharged
- •Patient is willing to comply with specified follow-up evaluations
- •Patient is 13 years of age or older
排除标准
- •Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;
- •Patient has/had active endocarditis within the last 3 months
- •Patient requires replacement of a native or previously implanted prosthetic, tricuspid, pulmonic or aortic valve;
- •Patient was previously enrolled and implanted in the study
- •Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ
- •Patient has a body surface area (BSA) > 1.9m2
- •Female patients who are pregnant, planning to become pregnant, or lactating
- •Patient has a documented history of substance ( drug or alcohol) abuse
- •Patient is currently a prison inmate
- •Patient is currently participating in an investigational drug or another device study
- •Patient is undergoing renal dialysis for chronic renal failure or has hyperparathyroidism
- •Patient has active myocarditis
- •Patient has had an acute preoperative neurological deficit, myocardial infarction, or cardiac event and has not returned to baseline or stabilized > 30 days prior to the planned v alve implant surgery
- •Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might place
研究组 & 干预措施
All subjects receive implant
Subjects serve as own control
干预措施: Implantation of CEP Magna Mitral Model 7000TFX (Device)
结局指标
主要结局
Percent of Late Adverse Events
时间窗: Events occurring >= 31 days and up through 5 years post-implant
Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
Percent of Early Adverse Events Divided
时间窗: Events occuring within 30 days of procedure
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.
Percentage of Subjects With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
时间窗: >30 Days, 1 Year, 2 Years, 3 Years, 4 Years, and 5 Years post-implant
Subject's freedom from Serious Adverse Events at \> 30 days post-implant. Time to events were estimated by Kaplan-Meier method.
Subject's Average Effective Orifice Area (EOA) Measurement
时间窗: Pre-procedure and 1 Year post-Implant
Effective orifice area represents the cross-sectional area of the blood flow downstream of the mitral valve. Effective orifice area is evaluated by echocardiography over time.
次要结局
未报告次要终点