Atrial Fibrillation
Conditions
Brief 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
Interventions
OTHERD-dimer assay before ablation of atrial fibrillation
Blood sample collection for D-dimers measurement
Sponsors
Medtronic
Groupe Hospitalier de la Rochelle Ré Aunis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\> 18 years. * Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter * Patient informed of the study
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound | up to 48 hours before ablation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CHADS2 Score | 48 hours before ablation | CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1) |
| Risk Factors | 48 hours before ablation | variables related to the presence of atrial thrombus |
| Atrial Thrombus Exclusion (ATE) Score | 48 hours before ablation | 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 |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Atrial Fibrillation D-dimer assay before ablation of atrial fibrillation
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement | 2,494 |
| Total | 2,494 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 12 |
Baseline characteristics
| Characteristic | Atrial Fibrillation |
|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 10.7 |
| Anticoagulation APIXABAN | 321 Participants |
| Anticoagulation DABIGATRAN | 269 Participants |
| Anticoagulation Effective Vitamin K antagonists | 814 Participants |
| Anticoagulation No anticoagulant therapy | 235 Participants |
| Anticoagulation Non effective Vitamin K antagonists | 245 Participants |
| Anticoagulation Other | 14 Participants |
| Anticoagulation RIVAROXABAN | 596 Participants |
| Left atrial tachycardia | 163 Participants |
| left ventricular ejection fraction | 57.4 percentage of ejection fraction STANDARD_DEVIATION 10 |
| Medical history Diabetes mellitus | 227 Participants |
| Medical history Heart failure | 304 Participants |
| Medical history Hypertension | 916 Participants |
| Medical history Infectious disease | 6 Participants |
| Medical history Inflammatory disease | 34 Participants |
| Medical history Neoplasia | 25 Participants |
| Medical history Previous left atrial ablation | 593 Participants |
| Medical history Recent surgery | 4 Participants |
| Medical history Stroke | 115 Participants |
| Medical history Venous thromboembolism | 45 Participants |
| Paroxysmal fibrillation | 1335 Participants |
| Persistent fibrillation | 996 Participants |
| Region of Enrollment France | 2494 participants |
| Sex: Female, Male Female | 676 Participants |
| Sex: Female, Male Male | 1818 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,506 |
| other Total, other adverse events | 0 / 2,506 |
| serious Total, serious adverse events | 0 / 2,506 |
Outcome results
Primary
Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
Time frame: up to 48 hours before ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Atrial Fibrillation | Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound | 48 Participants |
Secondary
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
Time frame: 48 hours before ablation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | Atrial Thrombus Exclusion (ATE) Score | ATE score = 1 | 23 Participants |
| Atrial Fibrillation | Atrial Thrombus Exclusion (ATE) Score | ATE score = 3 | 10 Participants |
| Atrial Fibrillation | Atrial Thrombus Exclusion (ATE) Score | ATE score = 2 | 14 Participants |
| Atrial Fibrillation | Atrial Thrombus Exclusion (ATE) Score | ATE score = 4 | 1 Participants |
| Atrial Fibrillation | Atrial Thrombus Exclusion (ATE) Score | ATE score = 0 | 0 Participants |
| No Atrial Thrombus | Atrial Thrombus Exclusion (ATE) Score | ATE score = 4 | 2 Participants |
| No Atrial Thrombus | Atrial Thrombus Exclusion (ATE) Score | ATE score = 0 | 911 Participants |
| No Atrial Thrombus | Atrial Thrombus Exclusion (ATE) Score | ATE score = 1 | 965 Participants |
| No Atrial Thrombus | Atrial Thrombus Exclusion (ATE) Score | ATE score = 2 | 467 Participants |
| No Atrial Thrombus | Atrial Thrombus Exclusion (ATE) Score | ATE score = 3 | 101 Participants |
Secondary
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)
Time frame: 48 hours before ablation
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | CHADS2 Score | CHADS2 score = 0 | 5 Participants |
| Atrial Fibrillation | CHADS2 Score | CHADS2 score = 1 | 20 Participants |
| Atrial Fibrillation | CHADS2 Score | CHADS2 score = 2 | 13 Participants |
| Atrial Fibrillation | CHADS2 Score | CHADS2 score ≥ 3 | 10 Participants |
| No Atrial Thrombus | CHADS2 Score | CHADS2 score ≥ 3 | 126 Participants |
| No Atrial Thrombus | CHADS2 Score | CHADS2 score = 0 | 1277 Participants |
| No Atrial Thrombus | CHADS2 Score | CHADS2 score = 2 | 299 Participants |
| No Atrial Thrombus | CHADS2 Score | CHADS2 score = 1 | 744 Participants |
Secondary
Risk Factors
variables related to the presence of atrial thrombus
Time frame: 48 hours before ablation
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Atrial Fibrillation | Risk Factors | Female gender | 15 Participants |
| Atrial Fibrillation | Risk Factors | Heart failure | 19 Participants |
| Atrial Fibrillation | Risk Factors | Hypertension | 30 Participants |
| Atrial Fibrillation | Risk Factors | History of stroke | 6 Participants |
| Atrial Fibrillation | Risk Factors | Persistent fibrillation | 28 Participants |
| Atrial Fibrillation | Risk Factors | Previous left atrial ablation | 9 Participants |
| Atrial Fibrillation | Risk Factors | Diabetes mellitus | 9 Participants |
| Atrial Fibrillation | Risk Factors | Anticoagulation prior to ablation | 47 Participants |
| Atrial Fibrillation | Risk Factors | Age (≥ 75yrs) | 8 Participants |
| No Atrial Thrombus | Risk Factors | Anticoagulation prior to ablation | 2212 Participants |
| No Atrial Thrombus | Risk Factors | Age (≥ 75yrs) | 148 Participants |
| No Atrial Thrombus | Risk Factors | Female gender | 661 Participants |
| No Atrial Thrombus | Risk Factors | Persistent fibrillation | 968 Participants |
| No Atrial Thrombus | Risk Factors | Hypertension | 886 Participants |
| No Atrial Thrombus | Risk Factors | Diabetes mellitus | 218 Participants |
| No Atrial Thrombus | Risk Factors | Heart failure | 285 Participants |
| No Atrial Thrombus | Risk Factors | History of stroke | 109 Participants |
| No Atrial Thrombus | Risk Factors | Previous left atrial ablation | 584 Participants |