NCT03795298

Comparison of Anticoagulation With Left Atrial Appendage Closure After AF Ablation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,600 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation. A subject who signs informed consent is considered enrolled in the study. Subjects will be randomized to OAC or WATCHMAN FLX in equal fashion. Randomization will be stratified by sequential vs. concomitant planned ablation +/- WATCHMAN implantation, to help ensure balance of treatment assignments within the sequential and concomitant groups.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	WATCHMAN FLX Implant	Left atrial appendage closure with the WATCHMAN FLX device
DRUG	Market-approved OAC	Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.

Timeline

• Start date: 2019-05-20
• Primary completion: 2024-07-24
• Completion: 2024-07-24
• First posted: 2019-01-07
• Last updated: 2025-09-18
• Results posted: 2025-09-18

Locations

114 sites across 10 countries: United States, Australia, Belgium, Denmark, France, Germany, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated device study