Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis

NCT07282002 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2025-CAR-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infective Endocarditis (IE)

Keywords

AngioVac; Infective endocarditis (IE)

Outcome Measures

Primary Outcomes (2)

• 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

  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

  48 hours post-procedure

Secondary Outcomes (25)

• 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

Study Arms (1)

AngioVac System

EXPERIMENTAL

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

Device: AngioVac System

Interventions

AngioVac System DEVICE

Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.

AngioVac System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angiodynamics, Inc.: lead

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Elizabeth Manning

CONTACT

3392372765; liz.manning@angiodynamics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 15, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04