NCT07282002尚未招募不适用
Feasibility Protocol for Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Rate of Clinical Success
研究概览
简要总结
The investigation aims to demonstrate initial safety and efficacy of the AngioVac System for the removal of vegetation in the right heart in patients with infective endocarditis.
详细描述
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
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 age ≥ 18 years
- •Subject provides a signed and dated Informed Consent Form
- •Subject has a diagnosis of native infective endocarditis
- •Subject has presence of bacteremia with valvular (tricuspid or pulmonic) vegetations > 1 cm confirmed by transesophageal echocardiogram (TEE) or transthoracic echocardiogram (TTE) with the presence of septic emboli
- •Subject has no underlying terminal illness and subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment
排除标准
- •Subject requires debulking of vegetation on cardiac leads
- •Subject has a prior history of ischemic/hemorrhagic stroke (within 3 months)
- •Subject has a coagulation disorder
- •Subject has arterial septic emboli
- •Subject has cerebral septic embolism
- •Subject has preoperative intubation due to ongoing hypoxemic respiratory failure
- •Subject has fungal endocarditis
- •Subject has atrial septal defect
- •Subject has medically refractory right-sided heart failure secondary to valvular dysfunction (SCAI SHOCK Stage Classification D or E)
- •Subject has planned valvular replacement/repair
- •Subject has prosthetic valves and/or annular abscesses
- •Subject has epidural abscesses
- •Subject is pregnant or breastfeeding
研究组 & 干预措施
AngioVac System
Experimental
Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit
干预措施: AngioVac System (Device)
结局指标
主要结局
Rate of Clinical Success
时间窗: 30 days post-procedure
The number and proportion of patients who experience clinical success, defined as a composite of 30-day survival, absence of persistent bacteremia within 30 days post-procedure, and absence of further right-sided valve intervention through 30 days post-procedure
Rate of Major Adverse Events (MAEs)
时间窗: 48 hours post-procedure
The number and proportion of subjects who experience a MAE within 48 hours post-procedure. MAEs include: all-cause mortality, major bleeding, and device- or procedure-related adverse events of cardiac perforation, vascular perforation, dissection, or pericardial effusion/tamponade
次要结局
- Blood loss(Periprocedural/immediately post-procedure)
- Intensive Care Unit (ICU) length of stay(Through ICU discharge, from date admitted to the ICU to date discharged from the ICU, up to 6 months post-procedure)
- Proportion of subjects completing follow-up at 30 days post-procedure(30 days post-procedure)
- Proportion of subjects completing follow-up at 6 months post-procedure(6 months post-procedure)
- Absolute change in vegetation size pre-procedure to post-procedure(Periprocedural/immediately post-procedure)
- Percent change in vegetation size pre-procedure to post-procedure(Periprocedural/immediately post-procedure)
- Intraoperative survival(Periprocedural/immediately post-procedure)
- In-hospital survival(Through hospital discharge, up to 6 months post-procedure)
- 30-day survival(30 days post-procedure)
- 6-month survival(6 months post-procedure)
- Absence of persistent bacteremia within 7 days post-procedure(7 days post-procedure)
- Absence of persistent bacteremia within 30 days post-procedure(30 days post-procedure)
- Absence of further right-sided valve intervention through 30 days post-procedure(30 days post-procedure)
- Absence of further right-sided valve intervention through 6 months post-procedure(6 months post-procedure)
- Increase in valvular regurgitation post-procedure(Periprocedural/immediately post-procedure)
- Increase in valvular regurgitation 7 days post-procedure(7 days post-procedure)
- Increase in valvular regurgitation 30 days post-procedure(30 days post-procedure)
- Increase in valvular regurgitation 6 months post-procedure(6 months post-procedure)
- Hospital length of stay(Through hospital discharge, from date admitted to the hospital to date discharged from the hospital, up to 6 months post-procedure)
- Transfusion secondary to periprocedural and post-procedural bleeding complications(Through hospital discharge, up to 6 months post-procedure)
- Rate of Device-Related Adverse Events (AEs)(Through 6 months post-procedure)
- All-cause mortality(Through 6 months post-procedure)
- Rate of Major Bleeding(Through 6 months post-procedure)
- Rate of device- or procedure-related individual Adverse Events of Special Interest (AESI)(Through 6 months post-procedure)
- Change in blood quality parameters(Through 30 days post-procedure)
研究者
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