NCT05324371已完成不适用
A Pilot Study to Assess WATCHMAN FLX™ Implants by Cardiac Computed Tomography, Magnetic Resonance Imaging and Transesophageal Echocardiography: WATCHMAN FLX™ CT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device
研究概览
简要总结
WATCHMAN FLX™ CT is a prospective, single-arm, single-center, post-market investigation to assess device tissue coverage in subjects with non-valvular atrial fibrillation (AF) who receive the WATCHMAN FLX device to reduce the risk of stroke. Serial advanced imaging modalities such as CT and TEE will be used.
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
- •Subject is of legal age to participate in the study per the laws of their respective geography.
- •Subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve).
- •Subject is clinically indicated for a WATCHMAN FLX device.
- •Subject is deemed suitable for the protocol-defined pharmacologic regimen.
- •Subject or legal representative is able to understand and willing to provide written informed consent to participate in the study.
- •Subject is able and willing to return for required follow-up visits and examinations.
排除标准
- •Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
- •Subject has eGFR <30 mL/min (chronic kidney disease stage IV or stage V).
- •Subject is contraindicated for TEE.
- •Subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction (e.g., due to an underlying hypercoagulable state).
- •Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
- •Subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment.
- •Subject had a prior major bleeding event per ISTH definitions within the 30 days prior to enrollment. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
- •Subject has an active bleed.
- •Subject has a reversible cause for AF or has transient AF.
- •Subject has no LAA or the LAA is surgically ligated.
- •Subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment.
- •Subject has a history of atrial septal repair or has an atrial septal defect/patent foramen ovale (ASD/PFO) device.
- •Subject has a known contraindication to percutaneous catheterization procedure.
- •Subject has a cardiac tumor.
- •Subject has signs/symptoms of acute or chronic pericarditis.
- •Subject has an active infection.
- •There is evidence of tamponade physiology.
- •Subject has New York Heart Association Class IV congestive heart failure at the time of enrollment.
- •Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study (method of assessment per study physician's discretion).
- •Subject has a documented life expectancy of less than 6 months.
结局指标
主要结局
Number of Participants With Any Hypoattenuated Thickening (HAT) on the Surface of the Device
时间窗: 14 days to 3 months post implant
Serial measurement of any HAT on the surface of the device at 14 days, 45 days and 3 months post implant as assessed by core lab using CT imaging
次要结局
未报告次要终点
研究者
研究点 (1)
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