Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 329
- 试验地点
- 30
- 主要终点
- Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort
研究概览
简要总结
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
详细描述
This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250, approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements. Subject enrollment will not start in the US before obtaining FDA approval of this post market study.
Assessments will be obtained for the preoperative and operative visits, and postoperatively at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications and coagulation profile. Blood data will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. Echocardiographic evaluation required for each subject preoperatively, at discharge, 6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will be completed by the subject pre-operatively and at the 6-month follow-up visit.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
- •The patient has signed and dated the subject informed consent form prior to surgery.
- •The patient is expected to survive the surgery and be discharged.
- •The patient is geographically stable and agrees to attend follow-up assessments.
- •The patient is 18 years or older.
排除标准
- •The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
- •The patient presents with active endocarditis within the last 3 months.
- •The patient is pregnant or lactating.
- •The patient is an intravenous drug abuser.
- •The patient is currently a prison inmate.
- •The patient is currently participating in a study of an investigational drug or device.
- •The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
- •The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*.
- •The patient was previously enrolled in the study.
- •The 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.
结局指标
主要结局
Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort
时间窗: Events occurring ≥ 31 days and up through 8 years post-implant
A linearized rate percentage is calculated by the following equation: \[(Total number of late adverse events in each category/total number of late patient years) x 100\]. Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact. Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
Primary Effectiveness Endpoints
时间窗: 8 years post-implant
The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.
次要结局
- Subject's Average Platelet Count Over Time(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Plasma Free Hemoglobin Over Time(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Cardiac Index Measurement(Baseline and 8 years post-implant)
- Subject's Average Left Ventricular Mass Regression(Baseline and 8 years post-implant)
- Subject's Average Red Blood Cell Count(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average White Blood Cell Count(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Hemoglobin Count(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Hematocrit Count(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Reticulocytes Percentage Over Time(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)
- Subject's Average Mean Gradient Measurement(Baseline and 8 years post-implant)
- Percent of Early Adverse Events(Events occurring within 30 days of procedure)
- Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time(6 months post-implant)
- Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort(Events occurring ≥ 31 days and up through 8 years post-implant)
- Subject's Average Peak Gradient Measurement(Baseline and 8 years post-implant)
- Subject's Average Effective Orifice Area (EOA) Measurement(Baseline and 8 years post-implant)
- Subject's Average Effective Orifice Area Index (EOAI) Measurement(Baseline and 8 years post-implant)
- Subject's Average Cardiac Output Measurement(Baseline and 8 years post-implant)
- Subject's Average Haptoglobin Over Time(6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits)