CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Dabigatran Etexilate Oral Capsuledrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03539055
NCT03539055Phase 4Completed
CompareCT.gov

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

Vanderbilt University Medical Center·interventional·Posted May 29, 2018·Updated Jun 10, 2025

In Brief

A Phase 4 clinical trial evaluating Dabigatran Etexilate Oral Capsule for Atrial Fibrillation and 3 related conditions. Completed, enrolled 100 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Device Related Thrombus, Left Atrial Appendage Thrombosis, Watchman LAA Closure Device
CountriesUnited States
CollaboratorsBoehringer Ingelheim

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedMay 29, 2018
Enrollment StartSep 1, 2018
Primary CompletionDec 31, 2023
Study CompletionFeb 29, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 8.1 years ago

Interventions

Dabigatran Etexilate Oral Capsuledrug

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.