Assessment of TRanscathetEr and Surgical Aortic BiOprosthetic Valve Dysfunction With Multimodality Imaging and Its TrEatment With Anticoagulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Frequency of patients with structural/functional abnormalities of bioprosthetic valves
研究概览
简要总结
This is a prospective study designed to evaluate the structural and functional integrity of transcatheter or surgical bioprosthetic valves with multimodality imaging. The study further aims to confirm resolution of the early bioprosthetic valve thrombotic changes with anticoagulation.
详细描述
Patients with a history of bioprosthetic valve replacement undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. The imaging studies will be performed at least 48-hours after bioprosthetic valve replacement. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy. I
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
- •Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment
- •Age 18 years or older
- •Ability to provide informed consent and follow-up with protocol procedures.
排除标准
- •Renal insufficiency (creatinine > 1.5 mg/dL)
- •Known allergy to iodinated contrast agents
研究组 & 干预措施
Pre-existing bioprosthetic aortic valve
Patients with a history of surgical or transcatheter valve replacement with bioprosthetic valves undergo cardiac contrast CT imaging and transthoracic echocardiography to evaluate structural and functional integrity of the aortic valves. Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy with Vitamin K antagonists (Warfarin) for 3 months with goal INR 2-3, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.
干预措施: Warfarin (Drug)
结局指标
主要结局
Frequency of patients with structural/functional abnormalities of bioprosthetic valves
时间窗: 3 months
次要结局
未报告次要终点
研究者
Raj Makkar
Associate Director, Cedars-Sinai Heart Institute; Professor of Medicine, University of California, Los Angeles; Director, Cardiac Catheterization Laboratories and Intervention Center
Cedars-Sinai Medical Center