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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AngioVac System | Experimental | Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AngioVac System | Device | Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 48 hours post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects completing follow-up at 30 days post-procedure | Proportion of subjects completing follow-up at 30 days post-procedure | 30 days post-procedure |
| Proportion of subjects completing follow-up at 6 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Manning | Contact | 3392372765 | liz.manning@angiodynamics.com |
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| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Proportion of subjects completing follow-up at 6 months post-procedure
| 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) | 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) | Periprocedural/immediately post-procedure |
| Intraoperative survival | Proportion of patients who survive the index procedure | Periprocedural/immediately post-procedure |
| In-hospital survival | Proportion of patients who survive to be discharged from the hospital | Through hospital discharge, up to 6 months post-procedure |
| 30-day survival | 30-day survival | 30 days post-procedure |
| 6-month survival | 6-month survival | 6 months post-procedure |
| Absence of persistent bacteremia within 7 days post-procedure | Absence of persistent bacteremia within 7 days post-procedure | 7 days post-procedure |
| Absence of persistent bacteremia within 30 days post-procedure | Absence of persistent bacteremia within 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 30 days post-procedure | 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 | 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) | Periprocedural/immediately post-procedure |
| Increase in valvular regurgitation 7 days post-procedure | Increase in valvular regurgitation 7 days post-procedure (TTE) | 7 days post-procedure |
| Increase in valvular regurgitation 30 days post-procedure | Increase in valvular regurgitation 30 days post-procedure (TTE) | 30 days post-procedure |
| Increase in valvular regurgitation 6 months post-procedure | Increase in valvular regurgitation 6 months post-procedure (TTE) | 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 | 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 | 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 | 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 | 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 | Through 6 months post-procedure |
| All-cause mortality | All-cause mortality | Through 6 months post-procedure |
| Rate of Major Bleeding | The number and proportion of subjects who experienced at Major Bleeding | 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 | 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 | Through 30 days post-procedure |