Skip to main content
OpenTrials
Completed

NCT Number: NCT05128110

Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests

    Time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: EHPAFAVE

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2021
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.