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

N/ANot Yet RecruitingNCT07282002

Angiodynamics, Inc.30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infective Endocarditis (IE)

Interventions

AngioVac SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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)

Central Contacts

Elizabeth Manning

CONTACT

3392372765 liz.manning@angiodynamics.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: Periprocedural/immediately post-procedure

Intraoperative survival

Proportion of patients who survive the index procedure

Time frame: Periprocedural/immediately post-procedure

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

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

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

Increase in valvular regurgitation 7 days post-procedure

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

Time frame: 7 days post-procedure

Increase in valvular regurgitation 30 days post-procedure

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

Time frame: 30 days post-procedure

Increase in valvular regurgitation 6 months post-procedure

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

Time frame: 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

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

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

Blood loss

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

Time frame: 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

Time frame: 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

Time frame: Through 6 months post-procedure

All-cause mortality

Time frame: Through 6 months post-procedure

Rate of Major Bleeding

The number and proportion of subjects who experienced at Major Bleeding

Time frame: 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

Time frame: 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

Time frame: Through 30 days post-procedure