NCT05128110

Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Anticoagulation monitoring is done by monitoring the ACT (Activated Clotting Time) with an objective greater than 300 s. Until now, treatment with direct oral anticoagulant (for the prevention of thromboembolic events of atrial fibrillation) was interrupted a few days before the procedure in order to limit the risk of per-procedural bleeding. However, 3 recent randomized studies concerning the 3 DOACs available suggest that treatment should not be interrupted during the entire operative period. The operation therefore takes place under double anticoagulation with a direct oral anticoagulant and unfractionated heparin. Under these conditions, ACT monitoring can no longer be considered a reliable means of measuring the level of anticoagulation. It was therefore necessary to explore the hemostasis of these patients in a broad way in order to avoid any risk of overdose of UFH (Unfractionated Heparin) during the procedure.

Conditions

• Hemostasis

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-11-30
• Completion: 2021-12-31
• First posted: 2021-11-19
• Last updated: 2022-01-26

Locations

1 site across 1 country: France