Not yet recruiting NCT07282002

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

No phase Interventional Infective Endocarditis (IE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: AngioVac System.
Who it may be relevant to: Registry conditions: Infective Endocarditis (IE). Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

Rate of Clinical Success [Time frame: 30 days post-procedure]
Rate of Major Adverse Events (MAEs) [Time frame: 48 hours post-procedure]

Secondary outcome measures (12)

Proportion of subjects completing follow-up at 30 days post-procedure [Time frame: 30 days post-procedure]
Proportion of subjects completing follow-up at 6 months post-procedure [Time frame: 6 months post-procedure]
Absolute change in vegetation size pre-procedure to post-procedure [Time frame: Periprocedural/immediately post-procedure]
Percent change in vegetation size pre-procedure to post-procedure [Time frame: Periprocedural/immediately post-procedure]
Intraoperative survival [Time frame: Periprocedural/immediately post-procedure]
In-hospital survival [Time frame: Through hospital discharge, up to 6 months post-procedure]
30-day survival [Time frame: 30 days post-procedure]
6-month survival [Time frame: 6 months post-procedure]
Absence of persistent bacteremia within 7 days post-procedure [Time frame: 7 days post-procedure]
Absence of persistent bacteremia within 30 days post-procedure [Time frame: 30 days post-procedure]
Absence of further right-sided valve intervention through 30 days post-procedure [Time frame: 30 days post-procedure]
Absence of further right-sided valve intervention through 6 months post-procedure [Time frame: 6 months post-procedure]

Eligibility criteria

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
Subject has prosthetic valves and/or annular abscesses
Subject has epidural abscesses
Subject is pregnant or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07282002 · 2025-CAR-01

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗