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

April 17, 2026 updated by: Angiodynamics, Inc.

Feasibility Protocol for 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AngioVac System
Percutaneous removal of right-heart vegetation using the AngioVac System Cannula and Circuit
Device: AngioVac System
Percutaneous vacuum-assisted aspiration of right-sided vegetation via suction, filtration and veno-venous bypass.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 days post-procedure
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
48 hours post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
30 days post-procedure
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
6 months post-procedure
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)
Periprocedural/immediately post-procedure
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)
Periprocedural/immediately post-procedure
Intraoperative survival
Time Frame: Periprocedural/immediately post-procedure
Proportion of patients who survive the index procedure
Periprocedural/immediately post-procedure
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
Through hospital discharge, up to 6 months post-procedure
30-day survival
Time Frame: 30 days post-procedure
30-day survival
30 days post-procedure
6-month survival
Time Frame: 6 months post-procedure
6-month survival
6 months post-procedure
Absence of persistent bacteremia within 7 days post-procedure
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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)
Periprocedural/immediately post-procedure
Increase in valvular regurgitation 7 days post-procedure
Time Frame: 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
Time Frame: 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
Time Frame: 6 months post-procedure
Increase in valvular regurgitation 6 months post-procedure (TTE)
6 months post-procedure
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
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
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
Through ICU discharge, from date admitted to the ICU to date discharged from the ICU, up to 6 months post-procedure
Blood loss
Time Frame: Periprocedural/immediately post-procedure
Amount of blood lost during the procedure (cc) per Investigator estimate
Periprocedural/immediately post-procedure
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
Through hospital discharge, up to 6 months post-procedure
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
Through 6 months post-procedure
All-cause mortality
Time Frame: Through 6 months post-procedure
All-cause mortality
Through 6 months post-procedure
Rate of Major Bleeding
Time Frame: Through 6 months post-procedure
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)
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
Through 6 months post-procedure
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
Through 30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Angiodynamics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-CAR-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Dietary Supplements

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