Hancock II Ultra Porcine Bioprosthesis Hemodynamic Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 5
- 主要终点
- The primary objective of the study is the hemodynamic performance of the bioprosthesis at 6 and 12 months after surgery.
研究概览
简要总结
Since the first implant in September 1982, the Medtronic Hancock® II has provided more than 20 years of excellent hemodynamic performance and durability. Design improvements over the past generations include: low profile, flexible stent, Supra-X™ supra-annular placement, T6 anti-calcification tissue treatment, modified fixation process, CINCH® advanced implant system and ULTRA™ minimized sewing ring. Valve sizing is a critical consideration in obtaining optimal hemodynamic performance. This is particular true in small aortic roots. A critical issue is the size of the prosthesis in relation to the patient's annulus.
The objective of this clinical study is to evaluate, at six and twelve months, the hemodynamic performance of the HancockÒ Ultra™ bioprosthesis in the aortic position, to analyze the incidence of patient prosthesis mismatch, correlation of gradients, and to ascertain frequency at which a larger valve size is used vs. a patient's debrided annulus diameter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients who require aortic valve replacement with or without coronary artery bypass grafting or surgical treatment of atrial fibrillation or mitral valve repair.
- •Patients who are able to provide informed consent.
排除标准
- •Concomitant procedures other than coronary artery bypass grafting, surgical treatment of atrial fibrillation or mitral valve repair.
- •Patients indicated for receiving a mechanical prosthesis.
- •Patients who will have a replacement of existing valve prosthesis.
- •Patients refusing or not able to provide informed consent.
- •Patients requiring emergency surgery.
- •Patients unable to participate in follow-up
结局指标
主要结局
The primary objective of the study is the hemodynamic performance of the bioprosthesis at 6 and 12 months after surgery.
时间窗: 6 and 12 months after surgery
This will be measured by comparing the mean aortic valve gradients pre- and post-surgery.Left ventricular mass regression will be compared pre operative and at 6 months follow-up. The follow-up data at 12 months will be used to see if there was any improvement with the 6 months follow-up visit. .
次要结局
- The secondary objective of the study is the incidence of patient prosthesis mismatch (PPM).(5 to 15 days post procedure)