Endocarditis, Bacterial, Endocarditis Infective, Intracardiac Mass, Intracardiac Thrombus, Intravascular Thrombosis, Thrombus Inferior Vena Cava, Thrombus of Pacemaker Electrode, Thrombus of Pulmonary Artery, Thrombus of Right Atrium, Thrombus of Right Ventricle, Thrombus on Catheter, Vegetation; Endocarditis, Vegetation; Heart, Vegetation on Catheter
Conditions
Keywords
Percutaneous aspiration, Intracardiac thrombus, Intravascular thrombus, Vegetation, Endocarditis, CIED lead associated vegetation
Brief summary
As a structured, multinational retrospective registry the AVATAR Registry addresses the following scientific aspects through systematic data collection, centralized quality control, and robust statistical analysis in patients that were treated with the AngioVac Aspiration System: 1. Quantify Real-World Safety: Composite adverse event rates across diverse populations and indications 2. Assess Effectiveness: Technical and clinical success rates stratified by indication 3. Identify Predictors: Clinical, procedural, and anatomical factors predicting success versus complications 4. Generate Publishable Cohorts: Sufficient statistical power (approx. 1000 patients across 8 indication cohorts) for: * Indication-specific outcomes * Multivariable prediction models * Time-to-event analyses (30-day and 12-month mortality) 5. Establish Best Practices: Evidence-based recommendations for patient selection, procedural technique, and follow-up
Detailed description
The AngioVac Aspiration System is a percutaneous device that enables removal of intravascular and intracardiac thrombotic or infectious material using a venovenous extracorporeal circuit with blood filtration and reinfusion. The system combines: * Direct aspiration of thrombi or vegetations * In-line blood filtration (protecting distal circulation) * Lower embolic risk compared to surgical extraction The AngioVac applications include the following clinical situations: 1. CIED-Related Pathology: Lead-associated thrombus and vegetations during cardiac implantable electronic device (CIED) extraction 2. Infective Endocarditis: Right-sided infective endocarditis with large vegetations 3. Venous Thrombosis: Central venous thrombi (SVC, IVC, iliofemoral) and right atrial/ventricular thrombi 4. Pulmonary Artery: Acute pulmonary artery thrombotic material 5. Malignancy-Associated: Cancer-associated thrombosis and catheter-associated thrombi Despite increasing clinical adoption, the evidence base remains limited: * Majority of published data consist of single-center case series with small cohorts * Heterogeneous reporting of outcomes, definitions, and complications across studies * Limited head-to-head comparisons with alternative interventions * Insufficient data on safety across diverse indications and patient phenotypes * Predictive factors for success and complications remain poorly characterized
Interventions
Participants are not assigned an intervention as part of the study
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age ≥18 years at time of AngioVac procedure 2. Patient underwent percutaneous AngioVac aspiration (any AngioVac model or version used clinically during study period) 3. Procedure performed within study period (January 2018 (or site's institutional start date) - June 2026) 4. Written informed consent OR documented waiver/exemption from ethics authority (per local regulations per GDPR)
Exclusion criteria
1. Insufficient documentation to assess primary safety or effectiveness endpoints (e.g. defined as \>20% missing data in core endpoint variables) 2. Patient objection to retrospective data use (where required by local law; GDPR Article 21 opt-out; honored without study impact) 3. Non-AngioVac procedures: Patients undergoing thrombus/vegetation removal by surgery or other percutaneous devices only (not AngioVac)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and technical effectiveness of AngioVac | From intervention to the end of 12month | Evaluation of in-hospital safety and procedural effectiveness of AngioVac in real-world practice across indications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Various secondary endpoints | From intervention to the end of 12month | Indication-stratified outcomes, predictors of technical success and adverse events, procedural resource use, device-related complications, and 30-day / 12-month follow-up where available. |
Countries
Germany
Contacts
Charité University Berlin, Deutsches Herzzentrum der Charité