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NCT05128110 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design

Related Conditions & MeSH terms

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]
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