This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Subject age ≥ 18 years
2. Subject provides a signed and dated Informed Consent Form
3. Subject has a diagnosis of native infective endocarditis
4. 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
5. Subject has no underlying terminal illness and subject is deemed medically eligible for interventional procedure(s) per institutional guidelines and/or clinical judgment
You may not be if
1. Subject requires debulking of vegetation on cardiac leads
2. Subject has a prior history of ischemic/hemorrhagic stroke (within 3 months)
3. Subject has a coagulation disorder
4. Subject has arterial septic emboli
5. Subject has cerebral septic embolism
6. Subject has preoperative intubation due to ongoing hypoxemic respiratory failure
7. Subject has fungal endocarditis
8. Subject has atrial septal defect
9. Subject has medically refractory right-sided heart failure secondary to valvular dysfunction (SCAI SHOCK Stage Classification D or E)
10. Subject has planned valvular replacement/repair
11. Subject has prosthetic valves and/or annular abscesses
12. Subject has epidural abscesses
13. Subject is pregnant or breastfeeding
Clareo Health | Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis
