ConditionInfective Endocarditis (IE)
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 groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov