Efficacy of Short Term Dabigatran Etexilate Followed by Aspirin Monotherapy After LAA (Left Atrial Appendage) Device Closure (the DEA-LAA Study).

NCT03539055 | Completed Phase 4 Results FDA Drug

• 1 other identifier: DEA-LAA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Atrial Fibrillation; Device Related Thrombus; Left Atrial Appendage Thrombosis; Watchman LAA Closure Device

Keywords

DRT; Device related thrombus; Dabigatran etexilate; Aspirin; Watchman

Outcome Measures

Primary Outcomes (2)

• Device Related Thrombus (DRT) at 90 Days

  Transesophageal echocardiogram or CT angiography determined presence of DRT at 90 days

  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

  90 days to 1 year

Secondary Outcomes (1)

• Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events

  Baseline to 90 days

Study Arms (1)

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.)

Drug: Dabigatran Etexilate Oral Capsule

Interventions

Dabigatran Etexilate Oral Capsule DRUG

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.

Also known as: Pradaxa

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

• 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.

  PMID: 25998141 BACKGROUND

• Lim 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.

  PMID: 28546017 BACKGROUND

• Kaneko 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.

  PMID: 28477098 BACKGROUND

• Fauchier 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.

  PMID: 29622159 BACKGROUND

• Pracon 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.

  PMID: 29463510 BACKGROUND

• Bergmann 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.

  PMID: 29313819 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Terry Weyand, MS., CCRP
• Organization: Vanderbilt Cardiovascular Research Enterprise

terry.l.weyand@vumc.org

6153229349

Study Officials

• Arvindh N Kanagasundram, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective single arm intervention of dabigatran etexilate with aspirin for 90 days following Watchman LAA device closure to prevent device related thrombus (DRT)

Study Record Dates

• First Submitted: May 12, 2018
• First Posted: May 29, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: February 29, 2024
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)