Study of Interference Between Oral Anticoagulants and Heparin During Ablation of Atrial Fibrillation (AF) or Left Atrial Tachycardia (GAD) by Catheter.

NCT05802576 | Completed

• 1 other identifier: APHP201314
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Catheter ablation of atrial fibrillation (AF) or left atrial tachycardia (GAD) is usually performed in patients treated with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) that are increasingly used. In some cases, patients need to have an unfractionated heparin relay (UFH) for the procedure. There are no recommendations for adjusting UFH doses during an AOD/UFH relay. DOACs interfere with the biological assay of UFH which poses a problem of adaptation of UFH doses in pre- and intra-procedure. The aim of the study is to evaluate the interference of residual DOAC on the measurement of anticoagulant activity of UFH in pre- and intra-procedure of AF ablation or GAD.

Conditions

Atrial Fibrillation; Atrial Tachycardia

Keywords

Atrial Fibrillation; Left Atrial Tachycardia; direct oral anticoagulants; unfractionated heparin

Outcome Measures

Primary Outcomes (3)

• Comparison of the specific anti-Xa activity of UFH (after filtration of the AOD) with the overall anti-Xa activity (without filtration)

  Comparison between the 4 groups by a 2-way ANOVA test and evaluation of their relationship by simple regression

  24 months

• Comparison between the 4 groups of UFH bolus doses

  Comparison between the 4 groups of UFH bolus doses required to obtain the target ACT by ANOVA or nonparametric assay according to normality of distribution.

  24 months

• The relationship between the specific anti-Xa activity of UFH or DOAC and ACT at different times of the study

  The relationship will be evaluated in each group by simple regression and by Bland and Altman graphs.

  24 months

Secondary Outcomes (2)

• Correlation between the occurrence of bleeding and/or thrombotic events and pre- and post-procedure DOAC and/or UFH concentrations

  24 months

• Comparison of the specific anti-Xa activity of UFH in groups with and without bleeding complications on the one hand or thrombotic on the other hand

  24 months

Study Arms (4)

Vitamin K

The vitamin K oral anticoagulant will be used on 25 patients.

Apixaban

The apixaban oral anticoagulant will be used on 25 patients.

Rivaroxaban

The rivaroxaban oral anticoagulant will be used on 25 patients.

Dabigatran

The dabigatran oral anticoagulant will be used on 25 patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring catheter AF/GAD ablation. Patients will be recruited during the usual follow-up in cardiology consultation. Patients will be divided into 4 groups depending on the oral anticoagulant used: * Vitamin K antagonists (n=25) * Apixaban (n=25) * Rivaroxaban (n=25) * Dabigatran (n=25)

You may qualify if:

• Patient aged 18 years and older
• Removal of AF or GAD in the left atrium provided by catheter
• Patient on oral anticoagulant: vitamin K antagonist, apixaban, rivaroxaban or dabigatran
• Patient informed and having given oral consent to participate in the research

You may not qualify if:

• Lack of social security affiliation
• Patient under guardianship or with curators
• Patient under state medical aid
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Bichat-Claude Bernard

Paris, 75018, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sample type : plasma. Quantity: 500. Plasma samples from blood samples will be frozen and will therefore be the subject of a biological collection.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Nadine Ajzenberg, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 6, 2023
• Study Start: July 8, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 2, 2023
• Last Updated: April 5, 2024

Record last verified: 2024-04

Locations

FR (1)