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.
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.
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.
- 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.
- 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.
- 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.
- Conditions
- Atrial Fibrillation, Atrial Tachycardia
- 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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
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
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.
- First posted6 Apr 2023
- Study start8 Jul 2021
- Primary completion30 Nov 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine Ajzenberg, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Interference Between Oral Anticoagulants and Heparin During Ablation of Atrial Fibrillation (AF) or Left Atrial Tachycardia (GAD) by Catheter
- ClinicalTrials.gov ID
- NCT05802576
- Acronym / sponsor ID
- FACADO / APHP201314
- Conditions
- Atrial Fibrillation, Atrial Tachycardia
- Keywords
- Atrial Fibrillation, Left Atrial Tachycardia, direct oral anticoagulants, unfractionated heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Lack of social security affiliation
- Patient under guardianship or with curators
- Patient under state medical aid
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Comparison between the 4 groups by a 2-way ANOVA test and evaluation of their relationship by simple regression
Comparison between the 4 groups of UFH bolus doses
Time frame: 24 months
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.
The relationship between the specific anti-Xa activity of UFH or DOAC and ACT at different times of the study
Time frame: 24 months
The relationship will be evaluated in each group by simple regression and by Bland and Altman graphs.
2 secondary outcomes
Correlation between the occurrence of bleeding and/or thrombotic events and pre- and post-procedure DOAC and/or UFH concentrations
Time frame: 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
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine Ajzenberg, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
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.