Left Atrial Appendage ClosureNCT03040622
The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
An observational study of Left Atrial Appendage Closure and WATCHMAN Device Implantation, run by Inova Health Care Services at 1 site in United States.
Trial summary
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after WATCHMAN implantation at several follow up visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Atrial Appendage Closure, WATCHMAN Device Implantation
- What is being tested?
- WATCHMAN Left Atrial Appendage Closure
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Subjects >18 years of age scheduled for left atrial appendage closure procedure with the WATCHMAN device.
Who may be able to join
- Subject indicated and scheduled for WATCHMAN device implantation at IHVI (Inova Heart and Vascular Institute)
- Subject may be of either sex and of any race, and must be >18 years of age.
- Subject must be willing and able to give appropriate informed consent.
- The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).
Who cannot join
- Subjects with contraindications for WATCHMAN device implantation
- Intracardiac thrombus is visualized by echocardiographic imaging, An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present, The LAA (Left atrial appendage) anatomy will not accommodate a device, Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE - transesophageal echocardiography probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present, There are contraindications to the use of warfarin, aspirin, or clopidogrel, The patient has a known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN Device is contraindicated
- Ligated or oversewn left atrium
- Concurrent participation in any investigational study.
- Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge
- History or evidence of any other clinically significant disorder, condition, or disease other than those outlined above that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Fairfax Hospital
Falls Church, Virginia, 22042
About this study
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after WATCHMAN implantation at several follow up visits.
- Being tested
- WATCHMAN Left Atrial Appendage Closure
- Keywords
- WATCHMAN, Left Atrial Appendage Closure, Thrombosis, Platelet Function
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WATCHMAN Left Atrial Appendage ClosureDevice
WATCHMAN Left Atrial Appendage Closure
| Study group | Role | What they receive |
|---|---|---|
| Watchman Left Atrial Appendage Closure | Not described Receives: Device: WATCHMAN Left Atrial Appendage Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Comparison of thrombin induced platelet-fibrin clot strength (TIP-FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. TIP-FCS >67mm has been associated with increased risk of hypercoagulability.
Measured: Assessed at 1 year post implant.
Secondary outcomes (3)
Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant
Comparison of fibrin clot strength (FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. FCS >32mm has been associated with increased risk of thrombosis.
Measured: Assessed at 1 year post implant.
Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Comparison of D-dimer levels as measured using ACL TOP 300 hemostasis testing system between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. D-dimer levels >500ng/ml are associated with thrombo-embolic diseases.
Measured: Assessed at 1 year post implant
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant
Number of participants with MACE [all-cause death, systemic or pulmonary embolism, MI (myocardial ischemia) , TIA (transient ischemic attack) , stroke, DRT, and BARC bleeding (2,3, or 5) ] post Watchman implant..
Measured: within 1-year post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2017 (estimated)
- Study start1 Mar 2017
- Primary completion15 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Left Atrial Appendage ClosureStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03040622
- Sponsor's protocol ID
- 16-2583
- Status last verified
- Oct 2023
- First submitted
- 4 Jan 2017
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gurbel PA, Bliden K, Sherwood M, Taheri H, Tehrani B, Akbari M, Yazdani S, Asgar JA, Chaudhary R, Tantry US. Development of a routine bedside CYP2C19 genotype assessment program for antiplatelet therapy guidance in a community hospital catheterization laboratory. J Thromb Thrombolysis. 2024 Apr;57(4):566-575. doi: 10.1007/s11239-024-02953-8. Epub 2024 Mar 13.
PubMed 38480590Sherwood M, Bliden KP, Ilkhanoff L, Venkataraman G, Strickberger A, Yazdani S, McSwain R, Rashid H, Navarese EP, Plummer T, Batchelor W, Chaudhary R, Tantry US, Gurbel PA. Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN) a case-control study. J Thromb Thrombolysis. 2020 Oct;50(3):484-498. doi: 10.1007/s11239-020-02205-5.
PubMed 32601850
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Thrombogenicity in Patients Undergoing WATCHMAN Left Atrial Appendage Closure Trial
- ClinicalTrials.gov ID
- NCT03040622
- Acronym / sponsor ID
- 16-2583
- Keywords
- WATCHMAN, Left Atrial Appendage Closure, Thrombosis, Platelet Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Feb 2017 (estimated)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate thrombogenicity in patients undergoing left atrial appendage closure using the WATCHMAN device. Parameters of thrombosis and platelet function, as well as other bio-markers, will be measure before, during, and after WATCHMAN implantation at several follow up visits.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Watchman Left Atrial Appendage Closure | – | Device: WATCHMAN Left Atrial Appendage Closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects >18 years of age scheduled for left atrial appendage closure procedure with the WATCHMAN device.
Key inclusion criteria (4 listed)
- Subject indicated and scheduled for WATCHMAN device implantation at IHVI (Inova Heart and Vascular Institute)
- Subject may be of either sex and of any race, and must be >18 years of age.
- Subject must be willing and able to give appropriate informed consent.
- The subject is able to read and has signed and dated the informed consent document including authorization permitting release of personal health information approved by the investigator's Institutional Review Board (IRB).
Key exclusion criteria (6 listed)
- Subjects with contraindications for WATCHMAN device implantation
- Intracardiac thrombus is visualized by echocardiographic imaging, An atrial septal defect repair or closure device or a patent foramen ovale repair or closure device is present, The LAA (Left atrial appendage) anatomy will not accommodate a device, Any of the customary contraindications for other percutaneous catheterization procedures (e.g., patient size too small to accommodate TEE - transesophageal echocardiography probe or required catheters) or conditions (e.g., active infection, bleeding disorder) are present, There are contraindications to the use of warfarin, aspirin, or clopidogrel, The patient has a known hypersensitivity to any portion of the device material or the individual components such that the use of the WATCHMAN Device is contraindicated
- Ligated or oversewn left atrium
- Concurrent participation in any investigational study.
- Subject likely to not be available to complete all protocol-required study visits or procedures, to the best of the subject's and investigator's knowledge
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 |
|---|---|---|
| WATCHMAN Left Atrial Appendage ClosureWATCHMAN Left Atrial Appendage Closure | Device | Watchman Left Atrial Appendage Closure |
Primary outcome
Comparison of Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Time frame: Assessed at 1 year post implant.
Comparison of thrombin induced platelet-fibrin clot strength (TIP-FCS) as measured using thromboelastography (TEG-6s) between patients with and without device related thrombosis (DRT) assessed by transesophageal echocardiogram after left atrial appendage closure (LAAC) with Watchman device. TIP-FCS >67mm has been associated with increased risk of hypercoagulability.
3 secondary outcomes
Comparison of Fibrin Clot Strength (FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year After Watchman Implant
Time frame: Assessed at 1 year post implant.
Comparison of D-dimer Levels Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant
Time frame: Assessed at 1 year post implant
Number of Participants With Major Adverse Clinical Events (MACE) Post Watchman Implant
Time frame: within 1-year post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38480590Gurbel PA, Bliden K, Sherwood M, Taheri H, Tehrani B, Akbari M, Yazdani S, Asgar JA, Chaudhary R, Tantry US. Development of a routine bedside CYP2C19 genotype assessment program for antiplatelet therapy guidance in a community hospital catheterization laboratory. J Thromb Thrombolysis. 2024 Apr;57(4):566-575. doi: 10.1007/s11239-024-02953-8. Epub 2024 Mar 13.
- Derived from this study: PubMed 32601850Sherwood M, Bliden KP, Ilkhanoff L, Venkataraman G, Strickberger A, Yazdani S, McSwain R, Rashid H, Navarese EP, Plummer T, Batchelor W, Chaudhary R, Tantry US, Gurbel PA. Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN) a case-control study. J Thromb Thrombolysis. 2020 Oct;50(3):484-498. doi: 10.1007/s11239-020-02205-5.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Left Atrial Appendage Closure and WATCHMAN Device Implantation, run by Inova Health Care Services at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 29 Mar 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Thrombin Induced Platelet-fibrin Clot Strength (TIP-FCS) Between Patients With and Without Device Related Thrombosis (DRT) Assessed at 1-year of Watchman Implant (time frame: Assessed at 1 year post implant.). 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 NCT03040622, which also lists 2 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 29 Mar 2024.