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New device sucks out deadly heart infections without open surgery

NCT ID NCT07282002

Disease control Sponsor: Angiodynamics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called AngioVac that uses suction to remove infected growths (vegetations) from the right side of the heart in people with infective endocarditis. The trial will enroll 30 adults with large vegetations and track survival, infection clearance, and complications within 30 days. If it works, it could offer a less invasive alternative to surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AngioVac System (a vacuum device to suction out infected growths from the heart)
What this could lead to
If successful, this could offer a less invasive way to remove dangerous heart infections, potentially reducing the need for open-heart surgery.
What could go wrong
This is a small, early feasibility study with only 30 participants, so results may not apply broadly. Risks include bleeding, heart perforation, or device-related complications.
Why investors are watching

AngioDynamics is testing its AngioVac System in a 30-patient feasibility trial to remove infected tissue, called vegetations, from the right side of the heart in people with infective endocarditis. For a small company, this readout matters because it could show whether the device works safely enough for a common, serious heart infection, which would open a larger market. A clear result, positive or negative, will shape how doctors and investors view the device's future.

If it works: A positive result could support broader use of AngioVac for endocarditis, potentially increasing sales of the device and its related products. It might also encourage larger studies that could lead to regulatory approvals in new patient groups.

If it fails: A failure or delay could hurt the company's reputation and slow adoption of the device, since trials in this area often fail to show clear benefit. The small size of the trial, 30 patients, also limits how much anyone can conclude from the results.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endocarditis infective endocarditis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infective endocarditis (IE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.