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NCT Number: NCT07769320

AngioVac Aspiration Therapy Registry

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité, Department of Cardiothoracic and Vascular Surgery

Berlin, 13353, Germany

Location contact

Prof. Dr. Christoph Starck

CONTACT

+49 30 4593 2055

Prof. Dr. Christoph Starck

PRINCIPAL_INVESTIGATOR

About this study

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:

  • CIED-Related Pathology: Lead-associated thrombus and vegetations during cardiac implantable electronic device (CIED) extraction
  • Infective Endocarditis: Right-sided infective endocarditis with large vegetations
  • Venous Thrombosis: Central venous thrombi (SVC, IVC, iliofemoral) and right atrial/ventricular thrombi
  • Pulmonary Artery: Acute pulmonary artery thrombotic material
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at time of AngioVac procedure
  • Patient underwent percutaneous AngioVac aspiration (any AngioVac model or version used clinically during study period)
  • Procedure performed within study period (January 2018 (or site's institutional start date) - June 2026)
  • Written informed consent OR documented waiver/exemption from ethics authority (per local regulations per GDPR)

Exclusion criteria

  • Insufficient documentation to assess primary safety or effectiveness endpoints (e.g. defined as >20% missing data in core endpoint variables)
  • Patient objection to retrospective data use (where required by local law; GDPR Article 21 opt-out; honored without study impact)
  • Non-AngioVac procedures: Patients undergoing thrombus/vegetation removal by surgery or other percutaneous devices only (not AngioVac)

Treatment and study plan

Retrospective analysis of assigned treatment

Other

Participants are not assigned an intervention as part of the study

Primary outcomes

  1. Safety and technical effectiveness of AngioVac

    Time frame: From intervention to the end of 12month

    Evaluation of in-hospital safety and procedural effectiveness of AngioVac in real-world practice across indications.

Secondary outcomes

  1. Various secondary endpoints

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Dr. med. Christoph Starck

CONTACT

[email protected]

+49 30 4593 2055

Thomas Haese, MSc, MA

CONTACT

[email protected]

+49 30 450 613 847

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Angiodynamics, Inc.
  • Deutsches Herzzentrum der Charité

Registry information

Official study title

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

Acronym: AVATaR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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