HemostasisEHPAFAVENCT05128110
Study of Hemostasis During the Atrial Fibrillation Ablation Procedure
An observational study of Hemostasis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemostasis
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who refused the use of their data for this study
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
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
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests
Measured: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Jan 2021
- Primary completion30 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles-Ambroise TACQUARD, MD, Principal investigator, Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128110
- Sponsor's protocol ID
- 7717
- Acronym
- EHPAFAVE
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Hemostasis During the Atrial Fibrillation Ablation Procedure
- ClinicalTrials.gov ID
- NCT05128110
- Acronym / sponsor ID
- EHPAFAVE / 7717
- Conditions
- Hemostasis
- Keywords
- Atrial fibrillation, Ablation, ACT, Heparin, Direct oral anticoagulant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 19 Nov 2021 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who refused the use of their data for this study
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
Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests
Time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]
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 26 Jan 2022.
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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.
Charles-Ambroise TACQUARD, MD principal investigator
Service d'Anesthésie et Réanimation chirurgicale - Hôpitaux Universitaires de Strasbourg
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 Hemostasis, run by University Hospital, Strasbourg, France 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 5 inclusion and 1 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 26 Jan 2022. 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?
Study of hemorrhagic and thrombotic complications and correlation with the various laboratory tests (time frame: Files analysed retrospectively from January 01, 2019 to December 31, 2019 will be examined]). 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 26 Jan 2022.