Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis
NCT ID: NCT07282002
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-03-31
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AngioVac System
Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit
AngioVac System
Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.
Interventions
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AngioVac System
Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Angiodynamics, Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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2025-CAR-01
Identifier Type: -
Identifier Source: org_study_id
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