A Novel Method for Cardiac Allograft Monitoring:Transbrachial Right Ventricle Endomyocardial Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Patient Satisfaction in Right endomyocardial biopsy via brachial access
研究概览
简要总结
This is an observational study that will recruit NYU Langone patients undergoing standard of care right ventricle endomyocardial biopsy. Patients who undergo planned RV-EMB via transbrachial access will be invited to take part in the study.
详细描述
Data including severity of tricuspid regurgitation and tamponade from pre and post procedure bedside echocardiograms, total procedure duration, radiation exposure and fluoroscopy time, sedatives used (if any) and bleeding/hematoma formation (if any) will be collected. A post-procedural survey will be administered to patients by study staff to assess comfort level and anxiety during procedure. A post procedure phone call will take place 3-5 days after procedure to assess for bruising, swelling or bleeding at the site of Brachial RV-EMB.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 18 to 90 years old
- •Patient is undergoing standard of care right heart catheterization with endomyocardial biopsy
- •Patient has right arm brachial access available
- •Patient is willing and able to provide written informed consent.
排除标准
- •Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula
- •Severe untreated tricuspid valve regurgitation
- •Female patients who are pregnant
结局指标
主要结局
Patient Satisfaction in Right endomyocardial biopsy via brachial access
时间窗: Day 1 to Day 540
Assessed by patients self report of their experience when undergoing right endomyocardial biopsy via brachial access compared to transjugular and transfemoral right ventricle endomyocardial biopsy.
次要结局
未报告次要终点