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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infective Endocarditis (IE)
• Intervention / Treatment: Device: AngioVac System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Manning; Phone Number: 3392372765; Email: liz.manning@angiodynamics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AngioVac System; Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit	Device: AngioVac System; Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects completing follow-up at 30 days post-procedure	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	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	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)	Periprocedural/immediately post-procedure
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)	Periprocedural/immediately post-procedure
Intraoperative survival	Proportion of patients who survive the index procedure	Periprocedural/immediately post-procedure
In-hospital survival	Proportion of patients who survive to be discharged from the hospital	Through hospital discharge, up to 6 months post-procedure
30-day survival	30-day survival	30 days post-procedure
6-month survival	6-month survival	6 months post-procedure
Absence of persistent bacteremia within 7 days post-procedure	Absence of persistent bacteremia within 7 days post-procedure	7 days post-procedure
Absence of persistent bacteremia within 30 days post-procedure	Absence of persistent bacteremia within 30 days post-procedure	30 days post-procedure
Absence of further right-sided valve intervention through 30 days post-procedure	Absence of further right-sided valve intervention through 30 days post-procedure	30 days post-procedure
Absence of further right-sided valve intervention through 6 months post-procedure	Absence of further right-sided valve intervention through 6 months post-procedure	6 months post-procedure
Increase in valvular regurgitation post-procedure	Increase in valvular regurgitation (i.e., mild to moderate or severe; moderate to severe) measured on imaging performed immediately pre-procedure to imaging performed immediately post-procedure (TEE)	Periprocedural/immediately post-procedure
Increase in valvular regurgitation 7 days post-procedure	Increase in valvular regurgitation 7 days post-procedure (TTE)	7 days post-procedure
Increase in valvular regurgitation 30 days post-procedure	Increase in valvular regurgitation 30 days post-procedure (TTE)	30 days post-procedure
Increase in valvular regurgitation 6 months post-procedure	Increase in valvular regurgitation 6 months post-procedure (TTE)	6 months post-procedure
Hospital length of stay	Number of days patients are in the hospital, from date admitted to date discharged from the hospital	Through hospital discharge, from date admitted to the hospital to date discharged from the hospital, up to 6 months post-procedure
Intensive Care Unit (ICU) length of stay	Number of days patients are in the Intensive Care Unit (ICU), from date admitted to the ICU to date discharged from the ICU	Through ICU discharge, from date admitted to the ICU to date discharged from the ICU, up to 6 months post-procedure
Blood loss	Amount of blood lost during the procedure (cc) per Investigator estimate	Periprocedural/immediately post-procedure
Transfusion secondary to periprocedural and post-procedural bleeding complications	Number of transfusions required secondary to periprocedural and post-procedural bleeding complications	Through hospital discharge, up to 6 months post-procedure
Rate of Device-Related Adverse Events (AEs)	The number and proportion of subjects who experienced at least one device-related adverse event during the study	Through 6 months post-procedure
All-cause mortality	All-cause mortality	Through 6 months post-procedure
Rate of Major Bleeding	The number and proportion of subjects who experienced at Major Bleeding	Through 6 months post-procedure
Rate of device- or procedure-related individual Adverse Events of Special Interest (AESI)	AESI include: cardiac perforation, vascular perforation, dissection, pericardial effusion, cardiac tamponade, pulmonary embolism, arterial thrombosis, venous thrombosis, acute kidney injury, acute liver injury, microangiopathy, micro-thrombotic disease, systemic inflammatory response syndrome (SIRS), and hemolysis	Through 6 months post-procedure
Change in blood quality parameters	Absolute difference and percent difference in blood quality parameters from baseline to post-procedure (immediately post-procedure), 7 days, hospital discharge, and 30 days	Through 30 days post-procedure

Collaborators and Investigators

• Sponsor: Angiodynamics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: AngioVac; Infective endocarditis (IE)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Endocarditis
• Other Study ID Numbers: 2025-CAR-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes