At a glance
ClinicalIndex Comparison RecordN/ACompleted· 949 enrolled
Drug / intervention
WATCHMAN FLX Pro LAAC Devicedevice
Likely dose
WATCHMAN FLX Pro Left Atrial Appendage Closure Device (no dose specified)AI-extracted
Key inclusion· 4
- ✓Documented non-valvular atrial fibrillation (absence of moderate or greater mitral stenosis or mechanical heart valve)
- ✓Clinically indicated for and treated or attempted with WATCHMAN FLX Pro device
- ✓Able and willing to return for required follow-up visits and examinations
- ✓Legal age and able to provide written informed consent
Key exclusion· 6
- ✕Life expectancy less than 6 months
- ✕Intracardiac thrombus present
- ✕Atrial septal defect repair/closure device or patent foramen ovale repair/closure device present
- ✕LAA anatomy cannot accommodate closure device
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
HEAL-LAA: Post-Market Real World Outcomes in WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device
In Brief
A clinical study evaluating WATCHMAN FLX Pro LAAC Device for Atrial Fibrillation and 2 related conditions. Completed, enrolled 949 participants across 45 sites.
Detailed Summary
The primary objective of this study is to collect real-world data on WATCHMAN FLX™ Pro Left Atrial Appendage Closure (LAAC) Device in patients with non-valvular atrial fibrillation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Bleeding, Stroke
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202420252026
First PostedApr 2023
Enrollment StartOct 2023
Primary CompletionJul 2024
Study CompletionSep 2025
TodayJul 2026
First PostedApr 12, 2023
Enrollment StartOct 3, 2023
Primary CompletionJul 15, 2024
Study CompletionSep 18, 2025
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago
Interventions
WATCHMAN FLX Pro LAAC Devicedevice
Treatment with a WATCHMAN FLX Pro Left Atrial Appendage Closure Device