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Atrial FibrillationFACADONCT05802576

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

An observational study of Atrial Fibrillation and Atrial Tachycardia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation, Atrial Tachycardia
Type of treatment
Pill or oral medicine
How many people
100 participants
Where
1 siteFrance
Study dates
8 Jul 2021to 2 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site
  • Hopital Bichat-Claude Bernard

    Paris, 75018

Other trials in France

About this study

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

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.

Read the detailed description

Atrial fibrillation (AF) is the most common heart rhythm disorder worldwide and is a major public health problem due to its increased morbidity and overall mortality, particularly related to stroke and heart failure. Catheter ablation is the most effective method for maintaining sinus rhythm and is currently recommended after failure of antiarrhythmic therapy in patients with symptomatic AF.

Spontaneous Atrial Left Tachycardia (ALT) is rarer, but is a common consequence after an initial procedure of persistent AF removal. The removal of AF, like that of ALT, is performed in the left atrium and is therefore associated with a major thromboembolic risk. The anticoagulation problems are the same for all ablations in the left atrium. Catheter ablation in the left atrium is usually performed in patients treated with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) that are increasingly used. In France, these are rivaroxaban and apixaban which are direct and selective inhibitors of factor Xa and dabigatran which directly and selectively inhibits free or clot-bound thrombin (factor IIa). DOACs are easier to use than VKAs and do not require regular biological monitoring either at initiation or in the follow-up of treatment. Based on current evidence from the AF literature, DOACs are comparable to VKAs with a lower risk of major bleeding.

Catheter ablation of AF or ALT exposes the patient to a hemorrhagic risk (hemopericardium for example) and especially thrombotic in intra-procedure ranging from 0.9 to 5%. Different mechanisms could be involved in this per-procedural prothrombotic situation: (1) activation of the contact phase by the ablation equipment, (2) lesion of the left atrial endothelium and release of pro-thrombotic cytokines from damaged cells, inflammatory reaction induced by the passage of transseptal sheaths (3) modification of blood flow after conversion to sinus rhythm. These different phenomena lead to the activation of coagulation. Conversely, excessive per-procedural anticoagulation exposes to a risk of bleeding. The management of patients under VKA is well codified and validated. In contrast, DOA treatment management is based solely on extrapolation of VKA data. Only a few observational studies have been performed in patients treated with DOAC but with a low thrombotic risk. Studies in those at high thrombotic risk are even rarer.

Our observational study proposes to compare at different times (pre-procedure, intra-procedure and post-procedure admission) the interference of DOACs on the determination of Unfractionated Heparin (UFH) in patients admitted for AF or catheter ALT removal in 25 patients treated with rivaroxaban, 25 patients treated with apixaban, and 25 patients treated with dabigatran, compared to 25 patients treated with VKA.

  1. in pre-procedure during the relay by UFH, we will determine the specific anti-Xa activity of UFH independently of AOD by neutralizing in vitro the anti-Xa activity of AOD by filtration.
  2. In per-procedure we will determine in these same patients the amount of UFH necessary to obtain a coagulation time measured by the satisfactory activating clotting time (ACT) (≥ 300 sec) to start the procedure. Anti-Xa activity will be performed in parallel to determine whether a correlation can be established between ACT and the specific anti-Xa activity of UFH or residual AOD.
  3. We will look for a relationship between the occurrence of hemorrhagic and / or thrombotic events and the concentrations of DOAC and / or UFH in pre- and post-procedure. Patients on VKA with standardized management procedures will be the control group.

This study will determine whether a dose modification of UFH should be considered based on the level of DOAC in the area of the disease.

Keywords
Atrial Fibrillation, Left Atrial Tachycardia, direct oral anticoagulants, unfractionated heparin
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05802576
Study groupRoleWhat they receive
Vitamin KThe vitamin K oral anticoagulant will be used on 25 patients.
ApixabanThe apixaban oral anticoagulant will be used on 25 patients.
RivaroxabanThe rivaroxaban oral anticoagulant will be used on 25 patients.
DabigatranThe dabigatran oral anticoagulant will be used on 25 patients.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 24 months

  2. 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.

    Measured: 24 months

  3. 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.

    Measured: 24 months

Secondary outcomes (2)
  1. Correlation between the occurrence of bleeding and/or thrombotic events and pre- and post-procedure DOAC and/or UFH concentrations

    Determine whether there is a correlation between the occurrence of bleeding and/or thrombotic events and pre- and post-procedure DOAC and/or UFH concentrations.

    Measured: 24 months

  2. 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

    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 by a Student test or by a nonparametric test (Mann-Whitney) according to the normality of the distribution

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start8 Jul 2021
  3. Primary completion30 Nov 2023
  4. Study completion2 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05802576
Sponsor's protocol ID
APHP201314
Acronym
FACADO
Status last verified
Apr 2024
First submitted
27 Mar 2023
Last updated
5 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Atrial Tachycardia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of the specific anti-Xa activity of UFH (after filtration of the AOD) with the overall anti-Xa activity (without filtration) (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.

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