Atrial FibrillationPhase 4DEA-LAANCT03539055
Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
A Phase 4 study testing Dabigatran Etexilate Oral Capsule in people with Atrial Fibrillation and Device Related Thrombus, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis
- What is being tested?
- Dabigatran Etexilate Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 29 Feb 2024
- Phase
- Phase 4
- 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
Who may be able to join
- Male or female sex, age >18 years.
- CHADS2 Vascular score of 3-9 and HAS BLED score 2 or higher meeting CMS coverage criteria for Watchman LAA closure device implantation.
- Able to give informed consent.
- Life expectancy of > 1year in the judgment of the implanting physician and shared decision-making physician.
Who cannot join
- Unable to give informed consent
- History of confirmed allergy to dabigatran etexilate
- Active cerebral bleeding, or active non-cerebral bleeding requiring blood transfusions (any absolute contra-indications to anti-coagulation).
- History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g. by surgery)
- Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery)
- Major bleeding episode (reduction in the haemoglobin level of at least 2g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) in one month prior to screening visit
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- Intolerance to dabigatran, if medication naïve, or other contra-indications as per the USPI, including ESRD on hemodialysis or GFR < 15ml/min, or concomitant use of rifampin.
- History of non-compliance, inability to follow-up.
- Pre-menopausal women (last menstruation ≤ 1 year prior to screening) who are not surgically sterile.
- Ischemic stroke or hemorrhagic stroke within 90 days of LAA placement.
- Anatomy unsuitable for LAA closure (incomplete surgical LAA ligation without suitable anatomy for Watchman placement. LAA ostial measurements >31mm, or <17mm in all views).
- Requires long-term oral anticoagulation therapy for a condition other than atrial fibrillation.
- ASA allergy, or confirmed allergy to nickel.
- Prior PFO or ASD closure device or prosthetic or mechanical heart valve.
- Acute MI within 90 days.
- Platelets <50,000 at time of Watchman LAAC implantation.
- Active endocarditis.
- Planning for endocardial catheter AF or left atrial ablation within 90 days of Watchman implantation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) to prevent device related thrombus.
Read the detailed description
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.).
The drug will be initiated on the morning following device implantation, taken BID per package insert dosing and until follow-up 90-day post implant TEE. Aspirin monotherapy will be utilized in conjunction at 81 mg for up to 12 months, after which the patients will be exited from the study and further treatment decisions will be made by the following physician (see Schedule of Study Procedures at end of protocol). The objective of this trial is to evaluate safety and efficacy of a 90-day period of dabigatran etexilate following LAA closure to prevent device associated thrombus, while minimizing adverse bleeding by eliminating the need for clopidogrel.
This is a single arm pilot study with the option (pending collaboration with additional funding source) to expand to a full single arm non-inferiority trial design with 80% power to detect a 1.4% difference with the non-inferiority margin 1% in absolute rate of DAT (control rate 3.9%).
Prospective, non-randomized single arm study. Comparison will be made to historical controls based on published one year DAT rates from PROTECT-AF, PREVAIL clinical trials, and EWOLUTION, and ACP/Amulet registries.
Echocardiography (TEE) will be performed at 90 days (3 months, +/- 2-week window), and again at 1-year post implant (+/- 4 weeks). Selected images will be interpreted by echo lab at coordinating center in an anonymous fashion (patient data de-identified). Ideal imaging will incorporate 0, 45, 90 and 135 degree angled views on the device at follow up.
Drug will be dispensed as part of the clinical trial supplied from the sponsor and each patient will receive a complete 90 days' supply up front. They will have a drug visit on the day of TEE with the research coordinator to hand back any remaining dabigatran, with clear instruction to stop the drug and only take ASA following confirmation of closure on TEE (no peri-device leak on Doppler of >5mm). A decision to continue anti-coagulation post closure 90day TEE will be made by the physician discretion based on TEE findings. If thrombus is found at the 90 days TEE, anti-coagulation may be extended another 6 weeks with repeat TEE imaging to confirm clot resolution at the discretion of the investigator. In the unlikely event of embolization or Doppler leak >5mm, decision on extending anti-coagulation, or re-implanting a device will be made by the following physician.
Additional baseline data collection: Patient demographics, medical history, age, sex, and prior use of anti-coagulants or anti-platelet medications will be collected. CHADS 2 Vasc, and HAS-BLED score calculated. Main indication for LAA closure must be documented. Baseline CBC and BMP required on day of implant or up to 1 week pre-procedure (typical standard of care labs at time of implant). This will include a recent calculation of Creatinine Clearance (using Cockroft Gault and using patients actual body weight) and dosing of study drug will be made in accordance (see below). Repeat PCV or hematocrit on the morning after Watchman LAAC implantation will be per hospital standard. PCV or hematocrit value pre-implant and at the post 90-day visit will be analyzed.
Calculation for dabigatran dosing:
CCr={ (l40-age) x weight in kg)/(72 x SCr) } x 0.85 (if female)
Implant procedure variables to collect include access site, sheath used for deployment (WAS), device size at implant and number of implant attempts. LA pressure mean if available. Presence of angiography contrast or Doppler Echo leak, thrombus, or pericardial effusion post implant will be recorded. At 90 days, TEE report findings and image review (standard of care) with drug dosing visit with research coordinator and return of any remaining study drug.
1 year TEE (standard of care) with a research exit visit with MD, physician extender, or research coordinator, with documentation of ASA tolerance, dosing, and any late bleeding episodes or hospitalizations (typically should be reported as AE/SAE when first knowledge of event is determined). TEE images will be sent to the primary study site (Vanderbilt University Medical Center) and core TEE lab will review to confirm presence or absence of DAT. In cases of CTA utilized for follow up, similarly images will be reviewed by chest radiology team at Vanderbilt.
Medication administration with 90 days of dabigatran to be dispensed by pharmacy ideally one time (180 capsules).
- Conditions
- Atrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis, Watchman LAA Closure Device
- Being tested
- Dabigatran Etexilate Oral Capsule
- Keywords
- DRT, Device related thrombus, Dabigatran etexilate, Aspirin, Watchman
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran Etexilate Oral CapsuleDrug
Also called Pradaxa
Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Dabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) Receives: Drug: Dabigatran Etexilate Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Related Thrombus (DRT) at 90 Days
Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days
Measured: Baseline to 90 days
Device Related Thrombus (DRT) at 1 Year
Transesophageal echocardiogram or CT angiography determined presence of DRT at 1 year post implant
Measured: 90 days to 1 year
Secondary outcomes (1)
Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events
Ischemic stroke, peripheral thrombo-embolic events and major bleeding events on dabigatran etexilate at 90 days
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2023
- Study completion29 Feb 2024
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 (6)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective single arm intervention of dabigatran etexilate with aspirin for 90 days following Watchman LAA device closure to prevent device related thrombus (DRT)
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Arvindh Kanagasundram, Vanderbilt University Medical Center
- Investigators
- Arvindh N Kanagasundram, MD, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539055
- Sponsor's protocol ID
- DEA-LAA
- Acronym
- DEA-LAA
- Status last verified
- Jun 2025
- First submitted
- 12 May 2018
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: RedCap database, central to primary center, online, web based and HIPAA compliant. Password protected and encrypted database.
Publications
Aryana A, Singh SK, Singh SM, O'Neill PG, Bowers MR, Allen SL, Lewandowski SL, Vierra EC, d'Avila A. Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization. Heart Rhythm. 2015 Jul;12(7):1431-7. doi: 10.1016/j.hrthm.2015.03.028. Epub 2015 May 18.
PubMed 25998141Lim YM, Kim JS, Kim TH, Uhm JS, Shim CY, Joung B, Hong GR, Lee MH, Jang YS, Pak HN. Delayed left atrial appendage contrast filling in computed tomograms after percutaneous left atrial appendage occlusion. J Cardiol. 2017 Dec;70(6):571-577. doi: 10.1016/j.jjcc.2017.04.007. Epub 2017 May 22.
PubMed 28546017Kaneko H, Neuss M, Weissenborn J, Butter C. Predictors of thrombus formation after percutaneous left atrial appendage closure using the WATCHMAN device. Heart Vessels. 2017 Sep;32(9):1137-1143. doi: 10.1007/s00380-017-0971-x. Epub 2017 May 5.
PubMed 28477098Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
PubMed 29622159Pracon R, Bangalore S, Dzielinska Z, Konka M, Kepka C, Kruk M, Kaczmarska-Dyrda E, Petryka-Mazurkiewicz J, Bujak S, Solecki M, Pskit A, Dabrowska A, Sieradzki B, Plonski A, Ruzyllo W, Witkowski A, Demkow M. Device Thrombosis After Percutaneous Left Atrial Appendage Occlusion Is Related to Patient and Procedural Characteristics but Not to Duration of Postimplantation Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Mar;11(3):e005997. doi: 10.1161/CIRCINTERVENTIONS.117.005997.
PubMed 29463510Bergmann MW, Ince H, Kische S, Schmitz T, Meincke F, Schmidt B, Foley D, Betts TR, Grygier M, Protopopov AV, Stein KM, Boersma LVA. Real-world safety and efficacy of WATCHMAN LAA closure at one year in patients on dual antiplatelet therapy: results of the DAPT subgroup from the EWOLUTION all-comers study. EuroIntervention. 2018 Apr 20;13(17):2003-2011. doi: 10.4244/EIJ-D-17-00672.
PubMed 29313819
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).
- ClinicalTrials.gov ID
- NCT03539055
- Acronym / sponsor ID
- DEA-LAA / DEA-LAA
- Conditions
- Atrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis, Watchman LAA Closure Device
- Keywords
- DRT, Device related thrombus, Dabigatran etexilate, Aspirin, Watchman
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) to prevent device related thrombus.
Detailed description
Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.).
The drug will be initiated on the morning following device implantation, taken BID per package insert dosing and until follow-up 90-day post implant TEE. Aspirin monotherapy will be utilized in conjunction at 81 mg for up to 12 months, after which the patients will be exited from the study and further treatment decisions will be made by the following physician (see Schedule of Study Procedures at end of protocol). The objective of this trial is to evaluate safety and efficacy of a 90-day period of dabigatran etexilate following LAA closure to prevent device associated thrombus, while minimizing adverse bleeding by eliminating the need for clopidogrel.
This is a single arm pilot study with the option (pending collaboration with additional funding source) to expand to a full single arm non-inferiority trial design with 80% power to detect a 1.4% difference with the non-inferiority margin 1% in absolute rate of DAT (control rate 3.9%).
Prospective, non-randomized single arm study. Comparison will be made to historical controls based on published one year DAT rates from PROTECT-AF, PREVAIL clinical trials, and EWOLUTION, and ACP/Amulet registries.
Echocardiography (TEE) will be performed at 90 days (3 months, +/- 2-week window), and again at 1-year post implant (+/- 4 weeks). Selected images will be interpreted by echo lab at coordinating center in an anonymous fashion (patient data de-identified). Ideal imaging will incorporate 0, 45, 90 and 135 degree angled views on the device at follow up.
Drug will be dispensed as part of the clinical trial supplied from the sponsor and each patient will receive a complete 90 days' supply up front. They will have a drug visit on the day of TEE with the research coordinator to hand back any remaining dabigatran, with clear instruction to stop the drug and only take ASA following confirmation of closure on TEE (no peri-device leak on Doppler of >5mm). A decision to continue anti-coagulation post closure 90day TEE will be made by the physician discretion based on TEE findings. If thrombus is found at the 90 days TEE, anti-coagulation may be extended another 6 weeks with repeat TEE imaging to confirm clot resolution at the discretion of the investigator. In the unlikely event of embolization or Doppler leak >5mm, decision on extending anti-coagulation, or re-implanting a device will be made by the following physician.
Additional baseline data collection: Patient demographics, medical history, age, sex, and prior use of anti-coagulants or anti-platelet medications will be collected. CHADS 2 Vasc, and HAS-BLED score calculated. Main indication for LAA closure must be documented. Baseline CBC and BMP required on day of implant or up to 1 week pre-procedure (typical standard of care labs at time of implant). This will include a recent calculation of Creatinine Clearance (using Cockroft Gault and using patients actual body weight) and dosing of study drug will be made in accordance (see below). Repeat PCV or hematocrit on the morning after Watchman LAAC implantation will be per hospital standard. PCV or hematocrit value pre-implant and at the post 90-day visit will be analyzed.
Calculation for dabigatran dosing:
CCr={ (l40-age) x weight in kg)/(72 x SCr) } x 0.85 (if female)
Implant procedure variables to collect include access site, sheath used for deployment (WAS), device size at implant and number of implant attempts. LA pressure mean if available. Presence of angiography contrast or Doppler Echo leak, thrombus, or pericardial effusion post implant will be recorded. At 90 days, TEE report findings and image review (standard of care) with drug dosing visit with research coordinator and return of any remaining study drug.
1 year TEE (standard of care) with a research exit visit with MD, physician extender, or research coordinator, with documentation of ASA tolerance, dosing, and any late bleeding episodes or hospitalizations (typically should be reported as AE/SAE when first knowledge of event is determined). TEE images will be sent to the primary study site (Vanderbilt University Medical Center) and core TEE lab will review to confirm presence or absence of DAT. In cases of CTA utilized for follow up, similarly images will be reviewed by chest radiology team at Vanderbilt.
Medication administration with 90 days of dabigatran to be dispensed by pharmacy ideally one time (180 capsules).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single arm intervention of dabigatran etexilate with aspirin for 90 days following Watchman LAA device closure to prevent device related thrombus (DRT)
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Dabigatran Etexilate Oral CapsuleDabigatran 75 or 150mg BID x 90 days plus ASA 81mg daily. Single arm, prospective unblinded study on post Watchman LAA closure device implant anti-coagulation management at a primary center (Vanderbilt Medical Center) and up to 5 additional high volume LAA implant centers. This trial will be designed to evaluate the use of dabigatran for 90 days post implantation of an LAA closure device (Watchman LAA Closure Device, Boston Scientific Inc.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female sex, age >18 years.
- CHADS2 Vascular score of 3-9 and HAS BLED score 2 or higher meeting CMS coverage criteria for Watchman LAA closure device implantation.
- Able to give informed consent.
- Life expectancy of > 1year in the judgment of the implanting physician and shared decision-making physician.
Key exclusion criteria (18 listed)
- Unable to give informed consent
- History of confirmed allergy to dabigatran etexilate
- Active cerebral bleeding, or active non-cerebral bleeding requiring blood transfusions (any absolute contra-indications to anti-coagulation).
- History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g. by surgery)
- Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery)
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 |
|---|---|---|
| Dabigatran Etexilate Oral CapsuleAlso: PradaxaOral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device. | Drug | Treatment arm |
Primary outcome
Device Related Thrombus (DRT) at 90 Days
Time frame: Baseline to 90 days
Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days
Device Related Thrombus (DRT) at 1 Year
Time frame: 90 days to 1 year
Transesophageal echocardiogram or CT angiography determined presence of DRT at 1 year post implant
1 secondary outcome
Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events
Time frame: Baseline to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25998141Aryana A, Singh SK, Singh SM, O'Neill PG, Bowers MR, Allen SL, Lewandowski SL, Vierra EC, d'Avila A. Association between incomplete surgical ligation of left atrial appendage and stroke and systemic embolization. Heart Rhythm. 2015 Jul;12(7):1431-7. doi: 10.1016/j.hrthm.2015.03.028. Epub 2015 May 18.
- Background: PubMed 28546017Lim YM, Kim JS, Kim TH, Uhm JS, Shim CY, Joung B, Hong GR, Lee MH, Jang YS, Pak HN. Delayed left atrial appendage contrast filling in computed tomograms after percutaneous left atrial appendage occlusion. J Cardiol. 2017 Dec;70(6):571-577. doi: 10.1016/j.jjcc.2017.04.007. Epub 2017 May 22.
- Background: PubMed 28477098Kaneko H, Neuss M, Weissenborn J, Butter C. Predictors of thrombus formation after percutaneous left atrial appendage closure using the WATCHMAN device. Heart Vessels. 2017 Sep;32(9):1137-1143. doi: 10.1007/s00380-017-0971-x. Epub 2017 May 5.
- Background: PubMed 29622159Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, Fatemi M, Franceschi F, Guedeney P, Jacon P, Paziaud O, Venier S, Deharo JC, Gras D, Klug D, Mansourati J, Montalescot G, Piot O, Defaye P. Device-Related Thrombosis After Percutaneous Left Atrial Appendage Occlusion for Atrial Fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536. doi: 10.1016/j.jacc.2018.01.076.
- Background: PubMed 29463510Pracon R, Bangalore S, Dzielinska Z, Konka M, Kepka C, Kruk M, Kaczmarska-Dyrda E, Petryka-Mazurkiewicz J, Bujak S, Solecki M, Pskit A, Dabrowska A, Sieradzki B, Plonski A, Ruzyllo W, Witkowski A, Demkow M. Device Thrombosis After Percutaneous Left Atrial Appendage Occlusion Is Related to Patient and Procedural Characteristics but Not to Duration of Postimplantation Dual Antiplatelet Therapy. Circ Cardiovasc Interv. 2018 Mar;11(3):e005997. doi: 10.1161/CIRCINTERVENTIONS.117.005997.
- Background: PubMed 29313819Bergmann MW, Ince H, Kische S, Schmitz T, Meincke F, Schmidt B, Foley D, Betts TR, Grygier M, Protopopov AV, Stein KM, Boersma LVA. Real-world safety and efficacy of WATCHMAN LAA closure at one year in patients on dual antiplatelet therapy: results of the DAPT subgroup from the EWOLUTION all-comers study. EuroIntervention. 2018 Apr 20;13(17):2003-2011. doi: 10.4244/EIJ-D-17-00672.
- Individual participant dataSharing planned: No. RedCap database, central to primary center, online, web based and HIPAA compliant. Password protected and encrypted database.
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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.
Arvindh N Kanagasundram, MD study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dabigatran Etexilate Oral Capsule in people with Atrial Fibrillation and Device Related Thrombus, run by Vanderbilt University Medical Center 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 18 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 10 Jun 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2025). 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?
Device Related Thrombus (DRT) at 90 Days (time frame: Baseline to 90 days). The study lists 2 primary outcomes in all. 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 NCT03539055, which also lists 6 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 10 Jun 2025.