Atrial FibrillationNCT02199080

D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation

A study testing D-dimer assay before ablation of atrial fibrillation in people with Atrial Fibrillation, run by Groupe Hospitalier de la Rochelle Ré Aunis at 37 sites 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

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
What is being tested?: D-dimer assay before ablation of atrial fibrillation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,506 participants
Where: 37 sitesFrance
Study dates: 28 Jul 2014to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Age> 18 years.
Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
Patient informed of the study

Who cannot join

Age <18 years.
Patients under guardianship
Pregnant woman
Contraindication to transesophageal echocardiography
transesophageal echocardiography made in another center as the center of ablation
Refusal of the patient to participate in the study
Patient participating in another interventional study in which an intervention related to biomedical research is performed before the transesophageal echocardiography

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

France37 sites

Service de cardiologie, CH de la Région d'Annecy
Annecy
Centre Hospitalier d' Auxerre
Auxerre
Service de cardiologie, CH Avignon
Avignon
Clinique La Fourcade
Bayonne
Service de cardiologie, CHU Bordeaux
Bordeaux
Service de cardiologie, CHU Brest
Brest
Service de cardiologie, CHU Caen
Caen
Service de cardiologie, CHU Clermont Ferrand
Clermont-Ferrand
Service de cardiologie, AP Hôpital Henri Mondor
Créteil
Service de cardiologie, CHU Dijon
Dijon
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, 17019
Service de cardiologie, CH Le Mans
Le Mans
Service de cardiologie, CHU Limoges
Limoges
Service de cardiologie, HCL Groupement Est
Lyon
Service de cardiologie, APM Hôpital de La Timone
Marseille
Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP
Marseille
Service de cardiologie, Hôpital Saint Joseph
Marseille
Service de cardiologie, Institut Jacques Cartier
Massy
Service de cardiologie, CHR Metz Thionville
Metz
Service de cardiologie, CHI Le Raincy Montfermeil
Montfermeil
Service de cardiologie, CHU Nancy
Nancy
Service de cardiologie, Nouvelles Cliniques Nantaises
Nantes
Service de cardiologie, CHU Nîmes
Nîmes
Service de cardiologie, HP Les Franciscaines
Nîmes
Service de cardiologie, AP Hôpital la Pitié Salpêtrière
Paris
Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard
Paris
Service de cardiologie, Institut Mutualiste Montsouris
Paris
Service de cardiologie, CH Pau
Pau
Service de cardiologie, CHU Poitiers
Poitiers
Service de cardiologie, CHU Rennes
Rennes
Service de cardiologie, CHU Rouen
Rouen
Service de cardiologie, Centre Cardiologique du Nord
Saint-Denis
Service de cardiologie, CHU Saint Etienne
Saint-Etienne
Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques
Toulouse
Service de cardiologie, Clinique Saint Gatien
Tours
Service de cardiologie, Clinique Saint Joseph
Trélaze
Service de cardiologie, Polyclinique Vauban
Valenciennes

Other trials in France

About this study

Official title: Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

Conditions: Atrial Fibrillation
Being tested: D-dimer assay before ablation of atrial fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

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

D-dimer assay before ablation of atrial fibrillationOther
Blood sample collection for D-dimers measurement

Study groups in NCT02199080
Study group	Role	What they receive
Atrial fibrillation	Other	D-dimer assay before ablation of atrial fibrillation Receives: Other: D-dimer assay before ablation of atrial fibrillation

What is being measured

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

Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
Measured: up to 48 hours before ablation

Secondary outcomes (3)

CHADS2 Score
CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)
Measured: 48 hours before ablation
Risk Factors
variables related to the presence of atrial thrombus
Measured: 48 hours before ablation
Atrial Thrombus Exclusion (ATE) Score
The following thromboembolic risk factors mark 1 point if present in patient:
- hypertension = 1 point
- cardiac insufficiency = 1 point
- history of stoke = 1 point
- d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score
Measured: 48 hours before ablation

Timeline

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

28 Jul 2014May 2016

First posted24 Jul 2014 (estimated)
Study start28 Jul 2014
Primary completionJan 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02199080
Sponsor's protocol ID: 2014/P02/001
Other IDs: 2013-A01700-45
Status last verified: Oct 2023
First submitted: 22 Jul 2014
Last updated: 30 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Milhem A, Ingrand P, Treguer F, Cesari O, Da Costa A, Pavin D, Rivat P, Badenco N, Abbey S, Zannad N, Winum PF, Mansourati J, Maury P, Bader H, Savoure A, Sacher F, Andronache M, Allix-Beguec C, De Chillou C, Anselme F; ATE Study Group. Exclusion of Intra-Atrial Thrombus Diagnosis Using D-Dimer Assay Before Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):223-230. doi: 10.1016/j.jacep.2018.09.009. Epub 2018 Nov 1.
PubMed 30784695

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale
ClinicalTrials.gov ID: NCT02199080
Acronym / sponsor ID: 2014/P02/001
Conditions: Atrial Fibrillation
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,506 participants (actual)
Lead sponsor: Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
Collaborators: Medtronic
Study start: 28 Jul 2014
Primary completion: Jan 2016 (actual)
Study completion: May 2016 (actual)
First posted: 24 Jul 2014 (estimated)
Results: Posted 15 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Atrial fibrillation	Other	Other: D-dimer assay before ablation of atrial fibrillationD-dimer assay before ablation of atrial fibrillation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age> 18 years.
Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
Patient informed of the study

Key exclusion criteria (7 listed)

Age <18 years.
Patients under guardianship
Pregnant woman
Contraindication to transesophageal echocardiography
transesophageal echocardiography made in another center as the center of ablation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
D-dimer assay before ablation of atrial fibrillationBlood sample collection for D-dimers measurement	Other	Atrial fibrillation

Primary outcome

Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
Time frame: up to 48 hours before ablation

3 secondary outcomes

CHADS2 Score
Time frame: 48 hours before ablation
Risk Factors
Time frame: 48 hours before ablation
Atrial Thrombus Exclusion (ATE) Score
Time frame: 48 hours before ablation

Results and safety

Results posted to the registry on 15 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Atrial Fibrillation	2,506	2,494

Primary outcome: Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound

Time frame: up to 48 hours before ablation. Count of participants. Unit: Participants

Measure	Atrial Fibrillation n = 2494
Value	48

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious and non-serious adverse events (biological and clinical) that occured between the signature of the consent and the end of patient participation were reported. The duration of patient participation was 48 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Atrial Fibrillation	0 of 2,506 (0%)	0 of 2,506 (0%)	0 of 2,506

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30784695Milhem A, Ingrand P, Treguer F, Cesari O, Da Costa A, Pavin D, Rivat P, Badenco N, Abbey S, Zannad N, Winum PF, Mansourati J, Maury P, Bader H, Savoure A, Sacher F, Andronache M, Allix-Beguec C, De Chillou C, Anselme F; ATE Study Group. Exclusion of Intra-Atrial Thrombus Diagnosis Using D-Dimer Assay Before Catheter Ablation of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):223-230. doi: 10.1016/j.jacep.2018.09.009. Epub 2018 Nov 1.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.

Antoine MILHEM, MD principal investigator

Groupe Hospitalier de la Rochelle Ré Aunis

37 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing D-dimer assay before ablation of atrial fibrillation in people with Atrial Fibrillation, run by Groupe Hospitalier de la Rochelle Ré Aunis at 37 sites 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 3 inclusion and 7 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 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites 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?

Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound (time frame: up to 48 hours before ablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02199080, which also lists 1 linked publication.

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 30 Oct 2023.