Mosaic 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
- 43
- 试验地点
- 11
研究概览
简要总结
The special fixation methodology of the Mosaic Ultra stented procine bioprosthesis allows valves to maintain their natural leaflet structure and root geometry which prevents leaflet calcification and improves hemodynamic performance and a potential for increased durability. This study will document the hemodynamic performance, as assessed by echocardiographic recordings, at six months post implantation.
详细描述
1.0 STUDY PLAN 1.1. Study Objectives The objective of this clinical study is to evaluate the hemodynamic performance of the Mosaic Ultra™ stented porcine bioprosthesis in the aortic position.
1.2. Study Design This will be a prospective non randomized multi center clinical study designed to obtain hemodynamic data on the Mosaic Ultra™ stented porcine bioprosthesis. All participating centers follow a common clinical investigation plan.
1.3. Sample Size and Study Duration The basis for this study will be at least 60 MosaicÒ Ultra™ stented porcine bioprosthesis implants followed for six months.
2.0 PATIENT SELECTION 2.1. Patient Eligibility Criteria The patient population includes all patients who require aortic valve replacement for heart valve disease (acquired or congenital) and who are candidates for a bioprosthetic valve. Patients will be informed about the aspects of this study and will be asked to give their Informed Consent. The patient population must be geographically stable and able to attend one follow-up examination at the implanting center. Patients not willing or unable to fully participate in the follow-up will not be entered in the study.
2.2. Inclusion Criteria
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 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.
- •Patients who are able to provide informed consent.
排除标准
- •Concomitant procedures other than coronary artery bypass grafting or surgical treatment of Atrial Fibrillation.
- •Patients indicated for receiving a mechanical prosthesis.
- •Patients who will have a replacement of an existing valve prosthesis.
- •Patients refusing or not able to provide informed consent.
- •Patients requiring emergency surgery.