Direct Comparison of Cardiac CT With TEE to Evaluate Watchman FLX LAA Occluder Device Characteristics: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 10
- 主要终点
- Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.
研究概览
简要总结
The current standard of care for patients who underwent left atrial appendage closure (LAAC) is to have follow-up transesophageal echocardiogram (TEE) for device surveillance. TEE is an ultrasound of the heart done by placing a probe in the esophagus under conscious sedation. It does not use contrast but can be cumbersome to patients as it involves placing a probe in the esophagus. Cardiac computerized tomography angiography (cardiac CTA) is a non-invasive imaging modality that involves the use of certain types of x-rays, contrast (dye) and special computers to generate accurate images of the heart. Participants in this study will undergo both TEE and CTA on the same day 90 days after their LAAC procedure.
Participants will be in this research study for a period of 1 year, starting from the day of their scheduled LAAC procedure. Participants will undergo a TEE at 90 days after their procedure which is the standard of care imaging study after LAAC. As part of this study, participants will also undergo a cardiac CTA at 90 days as well. Participants will have a routine follow-up visit following device placement as per standard of care as well as a brief phone "check in" at 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Subjects >18 years old planned to undergo LAAC
- •eGFR ≥ 30 mL/min per 1.73 m2
排除标准
- •Subjects below the age of 18
- •non-English speaking subjects
- •eGFR < 30 mL/min per 1.73 m2
- •Subjects with history of contrast allergy
- •Pregnant women
结局指标
主要结局
Number of detected device-related thrombus (DRT) as measured by CT scan/TEE.
时间窗: 3 months
LAA patency percentage associated with intra device leak (IDL) as measured by CT scan/TEE.
时间窗: 3 months post procedure
LAA patency percentage associated with peri device leak (PDL) as measured by CT scan/TEE
时间窗: 3 months post procedure
LAA patency percentage associated with a combination of both PDL and IDL as measured by CT scan/TEE.
时间窗: 3 months post procedure
次要结局
- Average hypo-attenuated thickening (HAT) measured in millimeters (mm)(3 months)
- Average depth of implant measured in millimeters (mm)(3 months)
- Percent of compression as measured by CT scan/TEE(3 months)
- Average size of device measured in millimeters (mm)(3 months)
- Number of adverse events as measured by medical record(Up to 7 days)
研究者
Steven Filby, MD
Physician, Interventional Cardiology
University Hospitals Cleveland Medical Center