At a glance
ClinicalIndex Comparison RecordN/ACompleted· 458 enrolled
Drug / intervention
WATCHMAN FLXdevice
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.
Protection Against Embolism for Non-valvular AF Subjects: Investigational Device Evaluation of the WATCHMAN FLX™ LAA Closure Technology
In Brief
A clinical study evaluating WATCHMAN FLX for Atrial Fibrillation. Completed, enrolled 458 participants across 29 sites.
Detailed Summary
The study is a prospective, non-randomized, multi-center investigation to establish the safety and effectiveness of the WATCHMAN FLX™ Left Atrial Appendage Closure Device for subjects with non-valvular atrial fibrillation who are eligible for long-term anti-coagulation therapy to reduce the risk of stroke but who have a rationale to seek a non-pharmacologic alternative.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartMay 2018
Primary CompletionJan 2020
Study CompletionMar 2021
TodayJul 2026
First PostedMar 8, 2016
Enrollment StartMay 7, 2018
Primary CompletionJan 28, 2020
Study CompletionMar 12, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.3 years ago
Interventions
WATCHMAN FLXdevice
Left atrial appendage closure with WATCHMAN FLX