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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.

Conditions

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Infective Endocarditis (IE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AngioVac System

Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit

Group Type EXPERIMENTAL

AngioVac System

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Angiodynamics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Elizabeth Manning

Role: CONTACT

3392372765

Other Identifiers

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2025-CAR-01

Identifier Type: -

Identifier Source: org_study_id

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