Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

NCT05128110 | Completed

• 1 other identifier: 7717
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemostasis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient with an atrial fibrillation, perated for an atrial fibrillation procedure in the University hospital of Strasbourg and without interruption of the direct oral anticoagulant

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles-Ambroise TACQUARD, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 19, 2021
• Study Start: January 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: January 26, 2022

Record last verified: 2021-10

Locations

FR (1)