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Clinical Trials/NCT07282002
NCT07282002
Not yet recruiting
Not Applicable

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

Angiodynamics, Inc.0 sites30 target enrollmentStarted: April 1, 2026Last updated:
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InterventionsAngioVac System

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Rate of Clinical Success
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

AngioVac System

Experimental

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

Intervention: AngioVac System (Device)

Outcomes

Primary Outcomes

Rate of Clinical Success

Time Frame: 30 days post-procedure

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

Rate of Major Adverse Events (MAEs)

Time Frame: 48 hours post-procedure

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

Secondary Outcomes

  • Blood loss(Periprocedural/immediately post-procedure)
  • Intensive Care Unit (ICU) length of stay(Through ICU discharge, from date admitted to the ICU to date discharged from the ICU, up to 6 months 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(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)
  • In-hospital survival(Through hospital discharge, up to 6 months post-procedure)
  • 30-day survival(30 days post-procedure)
  • 6-month survival(6 months post-procedure)
  • Absence of persistent bacteremia within 7 days post-procedure(7 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(30 days post-procedure)
  • Absence of further right-sided valve intervention through 6 months post-procedure(6 months post-procedure)
  • Increase in valvular regurgitation post-procedure(Periprocedural/immediately post-procedure)
  • Increase in valvular regurgitation 7 days post-procedure(7 days post-procedure)
  • Increase in valvular regurgitation 30 days post-procedure(30 days post-procedure)
  • Increase in valvular regurgitation 6 months post-procedure(6 months post-procedure)
  • Hospital length of stay(Through hospital discharge, from date admitted to the hospital to date discharged from the hospital, up to 6 months post-procedure)
  • Transfusion secondary to periprocedural and post-procedural bleeding complications(Through hospital discharge, up to 6 months post-procedure)
  • Rate of Device-Related Adverse Events (AEs)(Through 6 months post-procedure)
  • All-cause mortality(Through 6 months post-procedure)
  • Rate of Major Bleeding(Through 6 months post-procedure)
  • Rate of device- or procedure-related individual Adverse Events of Special Interest (AESI)(Through 6 months post-procedure)
  • Change in blood quality parameters(Through 30 days post-procedure)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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