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AngioVac Aspiration Therapy Registry

A Multicenter, International, Retrospective Observational Study Evaluating the Safety and Effectiveness of the AngioVac System Across Clinical Indications

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07769320
Acronym
AVATaR
Enrollment
1000
Registered
2026-08-17
Start date
2026-10-01
Completion date
2027-12-31
Last updated
2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Charite University, Berlin, Germany
Lead SponsorOTHER
Angiodynamics, Inc.
CollaboratorINDUSTRY
Deutsches Herzzentrum der Charité
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Safety and technical effectiveness of AngioVacFrom intervention to the end of 12monthEvaluation of in-hospital safety and procedural effectiveness of AngioVac in real-world practice across indications.

Secondary

MeasureTime frameDescription
Various secondary endpointsFrom intervention to the end of 12monthIndication-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

CONTACTProf. Dr. med. Christoph Starck
christoph.starck@dhzc-charite.de+49 30 4593 2055
CONTACTThomas Haese, MSc, MA
thomas.haese@dhzc-charite.de+49 30 450 613 847
STUDY_CHAIRChristoph Starck, Prof. Dr. med.

Charité University Berlin, Deutsches Herzzentrum der Charité

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026