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NCT Number: NCT07282002

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.

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Key information

Conditions

Infective Endocarditis (IE) Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AngioVac System

Device

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

Primary outcomes

  1. 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

  2. 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

  1. Proportion of subjects completing follow-up at 30 days post-procedure

    Time frame: 30 days post-procedure

    Proportion of subjects completing follow-up at 30 days post-procedure

  2. Proportion of subjects completing follow-up at 6 months post-procedure

    Time frame: 6 months post-procedure

    Proportion of subjects completing follow-up at 6 months post-procedure

  3. Absolute change in vegetation size pre-procedure to post-procedure

    Time frame: Periprocedural/immediately 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)

  4. Percent change in vegetation size pre-procedure to post-procedure

    Time frame: Periprocedural/immediately 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)

  5. Intraoperative survival

    Time frame: Periprocedural/immediately post-procedure

    Proportion of patients who survive the index procedure

  6. In-hospital survival

    Time frame: Through hospital discharge, up to 6 months post-procedure

    Proportion of patients who survive to be discharged from the hospital

  7. 30-day survival

    Time frame: 30 days post-procedure

    30-day survival

  8. 6-month survival

    Time frame: 6 months post-procedure

    6-month survival

  9. Absence of persistent bacteremia within 7 days post-procedure

    Time frame: 7 days post-procedure

    Absence of persistent bacteremia within 7 days post-procedure

  10. Absence of persistent bacteremia within 30 days post-procedure

    Time frame: 30 days post-procedure

    Absence of persistent bacteremia within 30 days post-procedure

  11. 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 30 days post-procedure

  12. Absence of further right-sided valve intervention through 6 months post-procedure

    Time frame: 6 months post-procedure

    Absence of further right-sided valve intervention through 6 months post-procedure

  13. Increase in valvular regurgitation post-procedure

    Time frame: Periprocedural/immediately 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)

  14. Increase in valvular regurgitation 7 days post-procedure

    Time frame: 7 days post-procedure

    Increase in valvular regurgitation 7 days post-procedure (TTE)

  15. Increase in valvular regurgitation 30 days post-procedure

    Time frame: 30 days post-procedure

    Increase in valvular regurgitation 30 days post-procedure (TTE)

  16. Increase in valvular regurgitation 6 months post-procedure

    Time frame: 6 months post-procedure

    Increase in valvular regurgitation 6 months post-procedure (TTE)

  17. 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

    Number of days patients are in the hospital, from date admitted to date discharged from the hospital

  18. 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

    Number of days patients are in the Intensive Care Unit (ICU), from date admitted to the ICU to date discharged from the ICU

  19. Blood loss

    Time frame: Periprocedural/immediately post-procedure

    Amount of blood lost during the procedure (cc) per Investigator estimate

  20. Transfusion secondary to periprocedural and post-procedural bleeding complications

    Time frame: Through hospital discharge, up to 6 months post-procedure

    Number of transfusions required secondary to periprocedural and post-procedural bleeding complications

  21. Rate of Device-Related Adverse Events (AEs)

    Time frame: Through 6 months post-procedure

    The number and proportion of subjects who experienced at least one device-related adverse event during the study

  22. All-cause mortality

    Time frame: Through 6 months post-procedure

    All-cause mortality

  23. Rate of Major Bleeding

    Time frame: Through 6 months post-procedure

    The number and proportion of subjects who experienced at Major Bleeding

  24. Rate of device- or procedure-related individual Adverse Events of Special Interest (AESI)

    Time frame: Through 6 months post-procedure

    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

  25. Change in blood quality parameters

    Time frame: Through 30 days post-procedure

    Absolute difference and percent difference in blood quality parameters from baseline to post-procedure (immediately post-procedure), 7 days, hospital discharge, and 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Manning

CONTACT

[email protected]

3392372765

Sponsors and collaborators

Lead sponsor

Angiodynamics, Inc.

Industry

Registry information

Official study title

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

Acronym: PAVE

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 15, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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