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.
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 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
Single group
AngioVac System
DevicePercutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.
Rate of Clinical Success
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)
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
Proportion of subjects completing follow-up at 30 days post-procedure
Proportion of subjects completing follow-up at 30 days post-procedure
Proportion of subjects completing follow-up at 6 months post-procedure
Proportion of subjects completing follow-up at 6 months post-procedure
Absolute change in vegetation size pre-procedure to post-procedure
Absolute change in vegetation size immediately pre-procedure to immediately post-procedure, measured by comparing imaging performed immediately pre-procedure to imaging performed immediately post-procedure (TEE)
Percent change in vegetation size pre-procedure to post-procedure
Percent change in vegetation size immediately pre-procedure to immediately post-procedure, measured by comparing imaging performed immediately pre-procedure to imaging performed immediately post-procedure (TEE)
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