Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

Hemostasis Clinical Trial

— EHPAFAVE  

Official title:

Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05128110
• Other study ID #: 7717
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2021
• Est. primary completion date: November 30, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Hemostasis

Locations

Country	Name	City	State
France	Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]