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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03795298
Study type Interventional
Source Boston Scientific Corporation
Contact
Status Active, not recruiting
Phase N/A
Start date May 20, 2019
Completion date November 2024

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