NCT03539055: DEA-LAA

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

Completed Phase 4 Results posted Last updated 10 June 2025

What this trial tests

Phase 4 trial testing Dabigatran Etexilate Oral Capsule in Atrial Fibrillation in 100 participants. Completed in 29 February 2024.

Timeline

1 September 2018

Primary endpoint
31 December 2023

29 February 2024

Quick facts

Lead sponsor	Vanderbilt University Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	1 September 2018
Primary completion	31 December 2023
Estimated completion	29 February 2024
Sites	1 location across United States

Drugs / interventions tested

• Dabigatran Etexilate Oral Capsule

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Device Related Thrombus — all drugs for Device Related Thrombus →
• Left Atrial Appendage Thrombosis — all drugs for Left Atrial Appendage Thrombosis →
• Watchman LAA Closure Device — all drugs for Watchman LAA Closure Device →

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Atrial Fibrillation or Device Related Thrombus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Device Related Thrombus (DRT) at 90 Days Primary · Baseline to 90 days

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

Group	Value	95% CI
Treatment Arm	1

Device Related Thrombus (DRT) at 1 Year Primary · 90 days to 1 year

Transesophageal echocardiogram or CT angiography determined presence of DRT at 1 year post implant

Group	Value	95% CI
Treatment Arm	0

Includes Ischemic Stroke, Peripheral Thrombo-embolic Events and Major Bleeding Events Secondary · Baseline to 90 days

Ischemic stroke, peripheral thrombo-embolic events and major bleeding events on dabigatran etexilate at 90 days

Ischemic Stroke

Group	Value	95% CI
Treatment Arm	0

Peripheral thrombo-embolic events

Group	Value	95% CI
Treatment Arm	0

Major Bleeds requiring intervention

Group	Value	95% CI
Treatment Arm	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Enrollment to one year post procedure. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Arm

Serious: 8/88 (9%)

Deaths: 4/88

Serious adverse events (3 terms)

Reaction	System	Treatment Arm
GI Bleeding	Gastrointestinal disorders	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—
Pericardial effusion	Cardiac disorders	—

Other adverse events (8 terms — click to expand)

Reaction	System	Treatment Arm
Gastrointestinal side effect	Gastrointestinal disorders	—
Non-ST elevation MI	Cardiac disorders	—
Blurred Vision	Eye disorders	—
Pericardial Pain	Cardiac disorders	—
Pulmonary infection	Respiratory, thoracic and mediastinal disorders	—
Headache	General disorders	—
Hematuria	Renal and urinary disorders	—
Joint Pain	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: GI Bleeding, Respiratory Failure, Pericardial effusion.

Data from ClinicalTrials.gov NCT03539055 adverse events section.

Sponsor's own 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.) to prevent device related thrombus.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Left atrial appendage occlusion.
   Holmes DR, Korsholm K, Rodés-Cabau J, Saw J, et al · · 2023 · cited 74× · PMID 36760206 · DOI 10.4244/eij-d-22-00627