Surgical Treatment of Aortic Stenosis With a Next Generation Surgical Aortic Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 295
- 试验地点
- 12
- 主要终点
- Percent of Early Adverse Events
研究概览
简要总结
The purpose of this clinical investigation is to confirm that the safety and performance of the EDWARDS INTUITY Valve System.
详细描述
This is a two-phase, non-randomized, prospective, single arm, multi-center clinical investigation. Each subject in Phase 1 and Phase 2 is consented for a period of 5 years. All subjects will be assessed for clinical follow-up at the following intervals: Discharge, 1 month, 3 months, 1 year and annually thereafter until 5 years of follow-up is achieved per subject.
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
- •Inclusion Criteria:
- •18 years or older
- •Aortic stenosis or stenosis-insufficiency of aortic valve requiring a planned replacement as indicated in the preoperative evaluation;
- •Scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery, MAZE procedure, septal myectomy, pacemaker/ICD implant and or atrial appendage occlusion/removal.
- •Signed and dated the informed consent form prior to investigation procedures;
- •Geographically stable and agrees to attend Follow up assessments at the hospital of surgical services for a maximum of 5 years.
排除标准
- •Pure aortic insufficiency
- •Requires emergency surgery
- •Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention
- •Left ventricular ejection fraction of ≤ 25%
- •Active endocarditis within 3 months prior to the scheduled aortic valve replacement surgery
- •Concomitant valve (mitral, tricuspid, or pulmonic) disease requiring repair with an annuloplasty ring or replacement with prosthesis
- •Prior mitral, tricuspid or pulmonic valve surgery, which included implantation of a bioprosthetic valve, mechanical valve, or annuloplasty ring.
- •Myocardial infarction (MI) within 1 month prior to the scheduled aortic valve replacement surgery
- •Previously implanted with EDWARDS INTUITY Aortic valve; alcohol or drug abuser
- •Disease limiting life expectancy to less than 12 months
- •Pregnant or lactating
- •Currently participating in another drug or device clinical investigation;
- •Documented blood diatheses
- •Requires non-cardiac procedures such as carotid procedures or mediastinal tumor removal
- •Had a stroke or transient ischemic attack (TIA) within 6-months prior to scheduled aortic valve replacement surgery
- •Study site pre-operative echocardiographic assessment shows evidence of an intracardiac mass, thrombus, or vegetation
- •Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
- •Documented renal insufficiency as determined by Serum creatinine ≥ 200 µmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
- •Documented hyperparathyroidism
结局指标
主要结局
Percent of Early Adverse Events
时间窗: Events occuring within 30 days of procedure
Number of early adverse events occurring within 30 days of procedure divided by the total number of enrolled subjects times 100.
Percent of Late Adverse Events
时间窗: Events occurring >= 31 days and up through 5 years post-implant
Number of late adverse 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).
次要结局
未报告次要终点