Intracardiac ThrombusAVATaRNCT07769320
AngioVac Aspiration Therapy Registry
An observational study of Intracardiac Thrombus and Intracardiac Mass, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis
- What is being tested?
- Retrospective analysis of assigned treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent an AngioVac procedure during the specified and mentioned time period.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Charité - Universitätsmedizin Berlin, Deutsches Herzzentrum der Charité, Department of Cardiothoracic and Vascular Surgery
Berlin, 13353
Prof. Dr. Christoph Starck, +49 30 4593 2055
Prof. Dr. Christoph Starck
About this study
Official title: A Multicenter, International, Retrospective Observational Study Evaluating the Safety and Effectiveness of the AngioVac System Across Clinical Indications
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:
- Quantify Real-World Safety: Composite adverse event rates across diverse populations and indications
- Assess Effectiveness: Technical and clinical success rates stratified by indication
- Identify Predictors: Clinical, procedural, and anatomical factors predicting success versus complications
- Generate Publishable Cohorts: Sufficient statistical power (approx. 1000 patients across 8 indication cohorts) for:
Read more
- Indication-specific outcomes
- Multivariable prediction models
- Time-to-event analyses (30-day and 12-month mortality)
- 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:
- 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
- Conditions
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis, Vegetation; Heart, Vegetation; Endocarditis, Vegetation on Catheter
- Being tested
- Retrospective analysis of assigned treatment
- Keywords
- Percutaneous aspiration, Intracardiac thrombus, Intravascular thrombus, Vegetation, Endocarditis, CIED lead associated vegetation
- Medical subject headings
- Endocarditis, Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrospective analysis of assigned treatmentOther
Participants are not assigned an intervention as part of the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and technical effectiveness of AngioVac
Evaluation of in-hospital safety and procedural effectiveness of AngioVac in real-world practice across indications.
Measured: 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.
Measured: From intervention to the end of 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Intracardiac ThrombusStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Angiodynamics, Inc., Deutsches Herzzentrum der Charité
- Responsible party
- Principal investigator, Christoph Starck, Charite University, Berlin, Germany
- Investigators
- Christoph Starck, Prof. Dr. med., Study chair, Charité University Berlin, Deutsches Herzzentrum der Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769320
- Sponsor's protocol ID
- AVATaR Registry
- Acronym
- AVATaR
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 39807229El 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 39130180Heck 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 38833618Kaemmel 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 38193462Haupt 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 32787666Starck 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 31832358Starck 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, International, Retrospective Observational Study Evaluating the Safety and Effectiveness of the AngioVac System Across Clinical Indications
- ClinicalTrials.gov ID
- NCT07769320
- Acronym / sponsor ID
- AVATaR / AVATaR Registry
- Conditions
- Intracardiac Thrombus, Intracardiac Mass, Intravascular Thrombosis, Vegetation; Heart, Vegetation; Endocarditis, Vegetation on Catheter
- Keywords
- Percutaneous aspiration, Intracardiac thrombus, Intravascular thrombus, Vegetation, Endocarditis, CIED lead associated vegetation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Angiodynamics, Inc., Deutsches Herzzentrum der Charité
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Quantify Real-World Safety: Composite adverse event rates across diverse populations and indications
- Assess Effectiveness: Technical and clinical success rates stratified by indication
- Identify Predictors: Clinical, procedural, and anatomical factors predicting success versus complications
- 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)
- 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:
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent an AngioVac procedure during the specified and mentioned time period.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrospective analysis of assigned treatmentParticipants are not assigned an intervention as part of the study | Other | – |
Primary outcome
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.
1 secondary outcome
Various secondary endpoints
Time frame: From intervention to the end of 12month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Background: PubMed 39807229Marinacci 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.
- Background: PubMed 39130180El 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.
- Background: PubMed 38833618Heck 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.
- Background: PubMed 38193462Kaemmel 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.
- Background: PubMed 32787666Haupt 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.
- Background: PubMed 31832358Starck 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.
- Background: PubMed 31638648Starck 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christoph Starck, Prof. Dr. med. study chair
Charité University Berlin, Deutsches Herzzentrum der Charité
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracardiac Thrombus and Intracardiac Mass, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. med. Christoph Starck (+49 30 4593 2055, christoph.starck@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and technical effectiveness of AngioVac (time frame: From intervention to the end of 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07769320, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.