ClinicalTrials.gg
Not yet recruitingNCT07769320AVATaRUpdated Oct 20, 2026

AngioVac Aspiration Therapy Registry

An observational study in Intracardiac Thrombus, Intracardiac Mass and Intravascular Thrombosis, sponsored by Charite University, Berlin, Germany. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Primary conditionEndocarditis, BacterialRegistry: EndocarditisReclassifiedWhy we changed it
Registry
Endocarditis — the first condition term the registry derived for this study.
ClinicalTrials.gg
Endocarditis, Bacterial
Why
  1. The study's listed conditions name Endocarditis, Bacterial, a narrower term within Endocarditis.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Intracardiac Thrombus
  • Intracardiac Mass
  • Intravascular Thrombosis
  • Vegetation; Heart
  • Vegetation; Endocarditis
  • Vegetation on Catheter
  • Thrombus of Right Atrium
  • Thrombus of Right Ventricle
  • Thrombus Inferior Vena Cava
  • Thrombus of Pacemaker Electrode
  • Endocarditis Infective
  • Endocarditis, Bacterial
  • Thrombus of Pulmonary Artery
  • Thrombus on Catheter

Browse trials for

Keywords

  • Percutaneous aspiration
  • Intracardiac thrombus
  • Intravascular thrombus
  • Vegetation
  • Endocarditis
  • CIED lead associated vegetation
03

In context

Endocarditis, Bacterial Reclassified

22 studies on the registry are indexed under Endocarditis, Bacterial; 9 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 588 across 10 observational studies indexed under Endocarditis, Bacterial.

Browse Endocarditis, Bacterial studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Compared within Endocarditis, Bacterial, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Endocarditis. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who underwent an AngioVac procedure during the specified and mentioned time period.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 OR documented waiver/exemption from ethics authority (per local regulations per GDPR)

Exclusion criteria

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • OtherRetrospective analysis of assigned treatment

    Participants are not assigned an intervention as part of the study

06

What researchers measure

Primary outcomes

  1. Safety and technical effectiveness of AngioVac

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

    Time frame: From intervention to the end of 12month

Secondary outcomes

  1. Various secondary endpoints

    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.

    Time frame: From intervention to the end of 12month

07

Study locations

1 site
  • Charité - Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité, Department of Cardiothoracic and Vascular Surgery
    Berlin, 13353, Germany
    • Prof. Dr. Christoph Starck · Contact+49 30 4593 2055
    • Prof. Dr. Christoph Starck · Principal investigator
08

References and documents

Publications

  • Marinacci LX, Sethi SS, Paras ML, El Sabbagh A, Secemsky EA, Sohail MR, Starck C, Bearnot B, Yucel E, Schaerf RHM, Akhtar Y, Younes A, Patton M, Villablanca P, Reddy S, Enter D, Moriarty JM, Keeling WB, El Hajj Younes S, Kiell C, Rosenfield K. Percutaneous Mechanical Aspiration for Infective Endocarditis: Proceedings From an Inaugural Multidisciplinary Summit and Comprehensive Review. J Soc Cardiovasc Angiogr Interv. 2024 Nov 14;3(12):102283. doi: 10.1016/j.jscai.2024.102283. eCollection 2024 Dec. PubMed 39807229 ↗
  • El Sabbagh A, Yucel E, Zlotnick D, Moriarty JM, Younes S, Hamid N, Akhtar Y, Baddour LM, O'Gara P, Starck C, Bangalore S, Parikh SA, Rosenfield K, Sethi SS. Percutaneous Mechanical Aspiration in Infective Endocarditis: Applications, Technical Considerations, and Future Directions. J Soc Cardiovasc Angiogr Interv. 2024 Feb 20;3(4):101269. doi: 10.1016/j.jscai.2023.101269. eCollection 2024 Apr. PubMed 39130180 ↗
  • Heck R, Pitts L, Kaemmel J, Wert L, Falk V, Hindricks G, Starck C. Infectious mass debulking in lead-associated endocarditis with a percutaneous aspiration system. Europace. 2024 Jun 3;26(6):euae151. doi: 10.1093/europace/euae151. PubMed 38833618 ↗
  • Kaemmel J, Heck R, Lanmueller P, Wert L, Falk V, Starck CT. Treatment of cardiac implantable electronic device endocarditis in pacemaker-dependent patients utilizing a percutaneous aspiration system. Multimed Man Cardiothorac Surg. 2024 Jan 8;2024. doi: 10.1510/mmcts.2023.082. PubMed 38193462 ↗
  • Haupt B, Merkle F, Dreizler T, Falk V, Starck C. Technical implementation of percutaneous thrombus aspiration using the AngioVac system. Perfusion. 2021 May;36(4):352-356. doi: 10.1177/0267659120946734. Epub 2020 Aug 13. PubMed 32787666 ↗
  • Starck CT, Dreizler T, Falk V. The AngioVac system as a bail-out option in infective valve endocarditis. Ann Cardiothorac Surg. 2019 Nov;8(6):675-677. doi: 10.21037/acs.2019.11.04. No abstract available. PubMed 31832358 ↗
  • Starck CT, Schaerf RHM, Breitenstein A, Najibi S, Conrad J, Berendt J, Esmailian F, Eulert-Grehn J, Dreizler T, Falk V. Transcatheter aspiration of large pacemaker and implantable cardioverter-defibrillator lead vegetations facilitating safe transvenous lead extraction. Europace. 2020 Jan 1;22(1):133-138. doi: 10.1093/europace/euz283. PubMed 31638648 ↗

Individual participant data

Plan to share: Yes — Data from the study can be made available upon request from the study lead in a de-identified form. A data use agreement must be signed before access to data. Access is only granted to academic staff.

Supporting information: Study protocol

Time frame: see above

Access criteria: see above

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 12, 2026
First posted
Aug 17, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07769320
Collaborators
Angiodynamics, Inc., Deutsches Herzzentrum der Charité
Responsible party
Christoph Starck (Senior Consultant, Charite University, Berlin, Germany) — Principal investigator
First posted
Aug 17, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 20, 2026

Study contacts

Prof. Dr. med. Christoph Starck
Contact
christoph.starck@dhzc-charite.de
+49 30 4593 2055
Thomas Haese, MSc, MA
Contact
thomas.haese@dhzc-charite.de
+49 30 450 613 847
Christoph Starck, Prof. Dr. med.
study chair · Charité University Berlin, Deutsches Herzzentrum der Charité

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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