NCT06340997尚未招募不适用
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients With Mitral Stenosis.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients with Mitral Stenosis.
研究概览
简要总结
• Evaluation of the effect of PTMC on LAA function by TEE at least one month after the procedure and its effectiveness in prevention of thrombi formation and cerebrovascular complications.
详细描述
- Mitral stenosis (MS) is a disabling disease that limits the normal physical abilities of patients and considered as a major reason for hospital admissions . The leading cause of MS globally is rheumatic heart disease(RHD), which remains common in economically developing countries and continues to be a significant cause of morbidity and mortality.
- Chronic pressure and volume overload imposed by MS causes left atrial (LA) and Left Atrial Appendage (LAA) dysfunction leading to reduced blood flow velocities thereby producing stasis of blood, reduced LA and LAA ejection fraction and atrial fibrillation (AF).
- These factors predispose to formation of LA and LAA thrombi in MS and result in thromboembolic episodes. Risk of cerebrovascular accident (CVA) is increased approximately five-fold in non-rheumatic AF and 17-fold in patients with MS with AF. Even patients of MS in sinus rhythm with depressed LA and LAA function are at increased risk of CVA. Assessment of LAA function is helpful in predicting the risk of thromboembolism .
- PTMC can improve the function of the LAA by reducing the left atrial pressure and increasing the blood flow through the mitral valve.
- Echocardiography, particularly transesophageal echocardiography (TEE), is currently the modality of choice for evaluation of the LAA. Transesophageal echocardiography (TEE) allows semi-invasive, highly accurate imaging of the functional efficiency of LAA by LAA Doppler and Doppler tissue imaging (DTI) .
- MS causes decreased LAA Doppler and DTI velocities in patients even with sinus rhythm . So, this study aims to evaluate effect of successful PTMC on LAA function by TEE Doppler and DTI (doppler tissue imaging).
- Fractional area change (FAC): The FAC is a measure of the percentage of change in the area of the LAA during systole. A higher FAC indicates a more contractile LAA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patient eligible for PTMC as anatomical characteristics àpatient with sever MS (area 1.5cm2, echocardiographic score (Wilkins score ≤ 8, Cormier score 1 and 2 ...), contraindication or high risk to surgical MVR.
排除标准
- •Patient with mitral regurgitation more than grade II .
- •Patient not eligible to PTMC.
- •Patient with severe heart failure (NHYA class IV) .
- •Patient with previous Cerebrovascular accident .
- •Patient with contraindication to TEE ( esophageal disease like stricture , diverticuli, varices, ..., uncooperative patient )
结局指标
主要结局
Impact of Percutaneous Transvenous Mitral Commissurotomy on The Left Atrial Appendage Function in Patients with Mitral Stenosis.
时间窗: basline
Assessment of left atrial appendage function pre and post PTMC. This assessment will be carried out through echocardiography by describing if it contains thrombus or not.
次要结局
- Prevention of left atrial appendage thrombus.(basline)
研究者
Mohamed Ahmed Ali Ismail
Resident
Assiut University
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