Study of Hemostasis During the Atrial Fibrillation Ablation Procedure

NCT ID: NCT05128110

Last Updated: 2022-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemostasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles-Ambroise TACQUARD, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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7717

Identifier Type: -

Identifier Source: org_study_id

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