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

Browse trials for

• Endocarditis 170

Keywords

• AngioVac
• Infective endocarditis (IE)

Study arms

• Experimental
  AngioVac System

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

  Device: AngioVac System

Interventions

• DeviceAngioVac System

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

Primary outcomes

1. 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

2. 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

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. Intraoperative survival

   Proportion of patients who survive the index procedure

   Time frame: Periprocedural/immediately post-procedure

6. 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

7. 30-day survival

   30-day survival

   Time frame: 30 days post-procedure

8. 6-month survival

   6-month survival

   Time frame: 6 months post-procedure

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

   Absence of persistent bacteremia within 7 days post-procedure

   Time frame: 7 days post-procedure

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

    Absence of persistent bacteremia within 30 days post-procedure

    Time frame: 30 days post-procedure

11. 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

12. 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

13. 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

14. Increase in valvular regurgitation 7 days post-procedure

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

    Time frame: 7 days post-procedure

15. Increase in valvular regurgitation 30 days post-procedure

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

    Time frame: 30 days post-procedure

16. Increase in valvular regurgitation 6 months post-procedure

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

    Time frame: 6 months post-procedure

17. 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

18. 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

19. Blood loss

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

    Time frame: Periprocedural/immediately post-procedure

20. 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

21. 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

22. All-cause mortality

    All-cause mortality

    Time frame: Through 6 months post-procedure

23. Rate of Major Bleeding

    The number and proportion of subjects who experienced at Major Bleeding

    Time frame: Through 6 months post-procedure

24. 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

25. 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