CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Coronary ostia height differences.
研究概览
简要总结
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.
详细描述
Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center.
Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.
All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
- •Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
- •CT imaging of the thorax with iodinated contrast agent carried out before surgery;
- •Signed informed consent, inclusive of release of medical information.
排除标准
- •Aortic valve replacement in bicuspid valve or endocarditis;
- •Aortic valve replacement associated with surgery of ascending aorta/aortic root;
- •Aortic valve replacement associated with other cardiac valve surgery;
- •Previous cardiac surgery of any kind;
- •Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
- •Participation in another clinical trial that could interfere with the endpoints of this study;
- •Pregnant at time of screening;
- •Allergy or hypersensitivity to iodinated contrast agent;
- •End-stage renal disease on dialysis.
研究组 & 干预措施
Surgical Aortic Valve Replacement
Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.
干预措施: CT scan with contrast medium (Radiation)
结局指标
主要结局
Coronary ostia height differences.
时间窗: At least 90 days after surgery
Differences in coronary ostia height before and after surgical aortic valve replacement.
次要结局
- Coronary ostia height differences between different bioprostheses.(At least 90 days after surgery)