Infective Endocarditis (IE)PAVENCT07282002
Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis
A study testing AngioVac System in people with Infective Endocarditis (IE), run by Angiodynamics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE)
- What is being tested?
- AngioVac System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
- Conditions
- Infective Endocarditis (IE)
- Being tested
- AngioVac System
- Keywords
- AngioVac, Infective endocarditis (IE)
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioVac SystemDevice
Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.
| Study group | Role | What they receive |
|---|---|---|
| AngioVac System | Experimental | Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit Receives: Device: AngioVac System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 48 hours post-procedure
Secondary outcomes (25)
Proportion of subjects completing follow-up at 30 days post-procedure
Proportion of subjects completing follow-up at 30 days post-procedure
Measured: 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
Measured: 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)
Measured: 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)
Measured: Periprocedural/immediately post-procedure
Intraoperative survival
Proportion of patients who survive the index procedure
Measured: Periprocedural/immediately post-procedure
In-hospital survival
Proportion of patients who survive to be discharged from the hospital
Measured: Through hospital discharge, up to 6 months post-procedure
30-day survival
30-day survival
Measured: 30 days post-procedure
6-month survival
6-month survival
Measured: 6 months post-procedure
Absence of persistent bacteremia within 7 days post-procedure
Absence of persistent bacteremia within 7 days post-procedure
Measured: 7 days post-procedure
Absence of persistent bacteremia within 30 days post-procedure
Absence of persistent bacteremia within 30 days post-procedure
Measured: 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
Measured: 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
Measured: 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)
Measured: Periprocedural/immediately post-procedure
Increase in valvular regurgitation 7 days post-procedure
Increase in valvular regurgitation 7 days post-procedure (TTE)
Measured: 7 days post-procedure
Increase in valvular regurgitation 30 days post-procedure
Increase in valvular regurgitation 30 days post-procedure (TTE)
Measured: 30 days post-procedure
Increase in valvular regurgitation 6 months post-procedure
Increase in valvular regurgitation 6 months post-procedure (TTE)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through 6 months post-procedure
All-cause mortality
All-cause mortality
Measured: Through 6 months post-procedure
Rate of Major Bleeding
The number and proportion of subjects who experienced at Major Bleeding
Measured: 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
Measured: 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
Measured: Through 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study startApr 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective Endocarditis (IE)Studies of the same condition, open and under way.
- More trials run by Angiodynamics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angiodynamics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282002
- Sponsor's protocol ID
- 2025-CAR-01
- Acronym
- PAVE
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Protocol for Percutaneous AngioVac Vegetation Extraction (PAVE) to Remove Right Heart Vegetations in Patients With Infective Endocarditis
- ClinicalTrials.gov ID
- NCT07282002
- Acronym / sponsor ID
- PAVE / 2025-CAR-01
- Conditions
- Infective Endocarditis (IE)
- Keywords
- AngioVac, Infective endocarditis (IE)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Angiodynamics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AngioVac System | Experimental | Device: AngioVac SystemPercutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioVac SystemPercutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass. | Device | AngioVac System |
Primary outcome
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
25 secondary outcomes
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
Increase in valvular regurgitation post-procedure
Time frame: Periprocedural/immediately post-procedure
Increase in valvular regurgitation 7 days post-procedure
Time frame: 7 days post-procedure
Increase in valvular regurgitation 30 days post-procedure
Time frame: 30 days post-procedure
Increase in valvular regurgitation 6 months post-procedure
Time frame: 6 months post-procedure
Hospital length of stay
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
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
Time frame: Periprocedural/immediately post-procedure
Transfusion 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)
Time frame: Through 6 months post-procedure
All-cause mortality
Time frame: Through 6 months post-procedure
Rate of Major Bleeding
Time frame: Through 6 months post-procedure
Rate of device- or procedure-related individual Adverse Events of Special Interest (AESI)
Time frame: Through 6 months post-procedure
Change in blood quality parameters
Time frame: Through 30 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing AngioVac System in people with Infective Endocarditis (IE), run by Angiodynamics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Manning (3392372765, liz.manning@angiodynamics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Clinical Success (time frame: 30 days post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.