Infective Endocarditis (IE)
Conditions
Keywords
AngioVac, Infective endocarditis (IE)
Brief 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.
Detailed description
This is a prospective, multicenter, single-arm investigational device study evaluating safety and effectiveness.
Interventions
DEVICEAngioVac System
Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.
Sponsors
Angiodynamics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject age ≥ 18 years 2. Subject provides a signed and dated Informed Consent Form 3. Subject has a diagnosis of native infective endocarditis 4. 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 5. 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
1. Subject requires debulking of vegetation on cardiac leads 2. Subject has a prior history of ischemic/hemorrhagic stroke (within 3 months) 3. Subject has a coagulation disorder 4. Subject has arterial septic emboli 5. Subject has cerebral septic embolism 6. Subject has preoperative intubation due to ongoing hypoxemic respiratory failure 7. Subject has fungal endocarditis 8. Subject has atrial septal defect 9. Subject has medically refractory right-sided heart failure secondary to valvular dysfunction (SCAI SHOCK Stage Classification D or E) 10. Subject has planned valvular replacement/repair 11. Subject has prosthetic valves and/or annular abscesses 12. Subject has epidural abscesses 13. Subject is pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Clinical Success | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects completing follow-up at 30 days post-procedure | 30 days post-procedure | Proportion of subjects completing follow-up at 30 days post-procedure |
| Proportion of subjects completing follow-up at 6 months post-procedure | 6 months post-procedure | Proportion of subjects completing follow-up at 6 months post-procedure |
| Absolute change in vegetation size pre-procedure to post-procedure | 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) |
| Percent change in vegetation size pre-procedure to post-procedure | 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) |
| Intraoperative survival | Periprocedural/immediately post-procedure | Proportion of patients who survive the index procedure |
| In-hospital survival | Through hospital discharge, up to 6 months post-procedure | Proportion of patients who survive to be discharged from the hospital |
| 30-day survival | 30 days post-procedure | 30-day survival |
| 6-month survival | 6 months post-procedure | 6-month survival |
| Absence of persistent bacteremia within 7 days post-procedure | 7 days post-procedure | Absence of persistent bacteremia within 7 days post-procedure |
| Absence of persistent bacteremia within 30 days post-procedure | 30 days post-procedure | Absence of persistent bacteremia within 30 days post-procedure |
| Absence of further right-sided valve intervention through 30 days post-procedure | 30 days post-procedure | Absence of further right-sided valve intervention through 30 days post-procedure |
| Absence of further right-sided valve intervention through 6 months post-procedure | 6 months post-procedure | Absence of further right-sided valve intervention through 6 months post-procedure |
| Increase in valvular regurgitation post-procedure | 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) |
| Increase in valvular regurgitation 7 days post-procedure | 7 days post-procedure | Increase in valvular regurgitation 7 days post-procedure (TTE) |
| Increase in valvular regurgitation 30 days post-procedure | 30 days post-procedure | Increase in valvular regurgitation 30 days post-procedure (TTE) |
| Increase in valvular regurgitation 6 months post-procedure | 6 months post-procedure | Increase in valvular regurgitation 6 months post-procedure (TTE) |
| Hospital length of stay | 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 |
| Intensive Care Unit (ICU) length of stay | 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 |
| Blood loss | Periprocedural/immediately post-procedure | Amount of blood lost during the procedure (cc) per Investigator estimate |
| Transfusion secondary to periprocedural and post-procedural bleeding complications | Through hospital discharge, up to 6 months post-procedure | Number of transfusions required secondary to periprocedural and post-procedural bleeding complications |
| Rate of Device-Related Adverse Events (AEs) | Through 6 months post-procedure | The number and proportion of subjects who experienced at least one device-related adverse event during the study |
| All-cause mortality | Through 6 months post-procedure | All-cause mortality |
| Rate of Major Bleeding | Through 6 months post-procedure | The number and proportion of subjects who experienced at Major Bleeding |
| Rate of device- or procedure-related individual Adverse Events of Special Interest (AESI) | 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 |
| Change in blood quality parameters | 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 |
Contacts
CONTACTElizabeth Manning
Outcome results
None listed