An interventional study of AngioVac System in Infective Endocarditis (IE), sponsored by Angiodynamics, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Angiodynamics, Inc. · Not applicable, Interventional, and Treatment
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.
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 30 is below the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Angiodynamics, Inc. is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
Time frame: 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
Time frame: 48 hours post-procedure
Proportion of subjects completing follow-up at 30 days post-procedure
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
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
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)
Time frame: 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)
Time frame: Periprocedural/immediately post-procedure
Intraoperative survival
Proportion of patients who survive the index procedure
Time frame: Periprocedural/immediately post-procedure
In-hospital survival
Proportion of patients who survive to be discharged from the hospital
Time frame: Through hospital discharge, up to 6 months post-procedure
30-day survival
30-day survival
Time frame: 30 days post-procedure
6-month survival
6-month survival
Time frame: 6 months post-procedure
Absence of persistent bacteremia within 7 days 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
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
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
Absence of further right-sided valve intervention through 6 months post-procedure
Time frame: 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)
Time frame: Periprocedural/immediately post-procedure
Increase in valvular regurgitation 7 days post-procedure
Increase in valvular regurgitation 7 days post-procedure (TTE)
Time frame: 7 days post-procedure
Increase in valvular regurgitation 30 days post-procedure
Increase in valvular regurgitation 30 days post-procedure (TTE)
Time frame: 30 days post-procedure
Increase in valvular regurgitation 6 months post-procedure
Increase in valvular regurgitation 6 months post-procedure (TTE)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through 6 months post-procedure
All-cause mortality
All-cause mortality
Time frame: Through 6 months post-procedure
Rate of Major Bleeding
The number and proportion of subjects who experienced at Major Bleeding
Time frame: 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
Time frame: 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
Time frame: Through 30 days post-procedure
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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