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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAngiodynamics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Subject age ≥ 18 years

Subject provides a signed and dated Informed Consent Form

Subject has a diagnosis of native infective endocarditis

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

Disqualifiers

Subject requires debulking of vegetation on cardiac leads

Subject has a prior history of ischemic/hemorrhagic stroke (within 3 months)

Subject has a coagulation disorder

Subject has arterial septic emboli

Trial design

Treatments tested in this trial

  • AngioVac System

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators