At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,600 enrolled
Drug / intervention
Market-approved OAC +1 moredrug
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.
Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation
In Brief
A clinical study evaluating WATCHMAN FLX Implant and Market-approved OAC for Atrial Fibrillation. Completed, enrolled 1,600 participants across 114 sites in 10 countries.
Detailed Summary
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation
CountriesAustralia, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, United States
Collaborators--
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartMay 2019
Primary CompletionJul 2024
TodayJul 2026
First PostedJan 7, 2019
Enrollment StartMay 20, 2019
Primary CompletionJul 24, 2024
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 7.5 years ago
Interventions
WATCHMAN FLX Implantdevice
Left atrial appendage closure with the WATCHMAN FLX device
Market-approved OACdrug
Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.