Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05128110

Acronym

EHPAFAVE

Enrollment

Registered

2021-11-19

Start date

2021-01-01

Completion date

2021-12-31

Last updated

2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemostasis

Keywords

Atrial fibrillation, Ablation, ACT, Heparin, Direct oral anticoagulant

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Patients over 18 years-old * with an atrial fibrillation * Operated for an atrial fibrillation procedure in the University hospital of Strasbourg * Without interruption of the direct oral anticoagulant * For whom extended biological assessment has been made in routine practice

Exclusion criteria

* Patients who refused the use of their data for this study

Design outcomes

Primary

Measure	Time frame
Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests	Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]

Countries

France

Outcome results