A Pilot Study of Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Leaflet Motion
研究概览
简要总结
This is a prospective, randomized pilot study in patients undergoing Sugical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) to estimate the incidence of reduced leaflet motion and assess the impact of perioperative anticoagulation on the incidence of reduced leaflet motion.
详细描述
This will be a pilot prospective randomized controlled trial.The study will enroll 50 adult patients scheduled to undergo SAVR and 50 adult patients scheduled to undergo TAVR. Subjects who satisfy Inclusion/Exclusion Criteria will be approached for informed consent. Those who give informed consent will be enrolled. After induction of anesthesia, a computer program will be used to randomize patients to one of the 2 treatment groups.
- SAVR patients will get either Warfarin or aspirin
- TAVR patients will get either Warfarin or aspirin.
Patients will be seen at 4-6 weeks postoperatively for Transthoracic ECHO (TTE), 4 dimensional (4D), Multidetector computed tomography (MDCT) scan and review of medical history. Phone follow up at 6,9 and 12 months post-operatively.
Data from this pilot study will enable us to determine the feasibility of a larger randomized controlled clinical trial to investigate the phenomenon of reduced leaflet motion/subclinical valve thrombosis and, possibly, its clinical importance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Scheduled for SAVR or TAVR
- •Age > 18 years
- •Able and willing to give informed consent
- •Able and willing to return for follow up
排除标准
- •Contraindications to warfarin, Plavix or aspirin
- •Pre-existing medical indication for warfarin, Plavix or aspirin
- •History of previous cardiac surgery
- •History of previous coronary artery stenting
- •Requirement for concomitant coronary artery bypass grafting or mitral valve surgery or surgical treatment of an ascending aortic aneurysm
- •Contraindications to contrast-enhanced MDCT including anaphylactic iodine allergy, uncontrolled atrial fibrillation, renal dysfunction (GFR < 60 ml/min).
研究组 & 干预措施
TAVR Aspirin and Clopidogrel Arm
Aspirin (81mg/day) and Clopidogrel (75mg/day) arm
干预措施: TAVR Aspirin and clopidogrel (Drug)
SAVR Warfarin Arm
Warfarin arm-(target INR of 2-3)
干预措施: SAVR Warfarin (Drug)
TAVR Warfarin and Clopidogrel Arm
Warfarin (target INR of 2-3) and Clopidogrel (75mg/day) arm
干预措施: TAVR Warfarin and clopidogrel (Drug)
SAVR Aspirin Arm
Aspirin arm (81mg/day)
干预措施: SAVR Aspirin (Drug)
结局指标
主要结局
Leaflet Motion
时间窗: 4-6 weeks post procedure
Frequency of reduced leaflet motion related to perioperative anticoagulation with warfarin as measured by 4DMCT data. (\<50% reduction in motion), moderately reduced (50 to 70% reduction), severely reduced (\>70% reduction), or immobile (lack of motion of at least one valve leaflet).
次要结局
未报告次要终点
研究者
Douglas Johnston
MD
The Cleveland Clinic