Trial Outcomes & Findings for D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation (NCT NCT02199080)
NCT ID: NCT02199080
Last Updated: 2023-10-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2506 participants
Primary outcome timeframe
up to 48 hours before ablation
Results posted on
2023-10-30
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
2506
|
|
Overall Study
COMPLETED
|
2494
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Protocol Violation
|
12
|
Baseline Characteristics
D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Atrial Fibrillation
n=2494 Participants
D-dimer assay before ablation of atrial fibrillation
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement
|
|---|---|
|
Age, Continuous
|
60.7 years
STANDARD_DEVIATION 10.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
676 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1818 Participants
n=93 Participants
|
|
Region of Enrollment
France
|
2494 participants
n=93 Participants
|
|
Paroxysmal fibrillation
|
1335 Participants
n=93 Participants
|
|
Persistent fibrillation
|
996 Participants
n=93 Participants
|
|
Left atrial tachycardia
|
163 Participants
n=93 Participants
|
|
left ventricular ejection fraction
|
57.4 percentage of ejection fraction
STANDARD_DEVIATION 10.0 • n=93 Participants
|
|
Medical history
Previous left atrial ablation
|
593 Participants
n=93 Participants
|
|
Medical history
Hypertension
|
916 Participants
n=93 Participants
|
|
Medical history
Diabetes mellitus
|
227 Participants
n=93 Participants
|
|
Medical history
Heart failure
|
304 Participants
n=93 Participants
|
|
Medical history
Stroke
|
115 Participants
n=93 Participants
|
|
Medical history
Venous thromboembolism
|
45 Participants
n=93 Participants
|
|
Medical history
Inflammatory disease
|
34 Participants
n=93 Participants
|
|
Medical history
Neoplasia
|
25 Participants
n=93 Participants
|
|
Medical history
Infectious disease
|
6 Participants
n=93 Participants
|
|
Medical history
Recent surgery
|
4 Participants
n=93 Participants
|
|
Anticoagulation
No anticoagulant therapy
|
235 Participants
n=93 Participants
|
|
Anticoagulation
DABIGATRAN
|
269 Participants
n=93 Participants
|
|
Anticoagulation
RIVAROXABAN
|
596 Participants
n=93 Participants
|
|
Anticoagulation
APIXABAN
|
321 Participants
n=93 Participants
|
|
Anticoagulation
Effective Vitamin K antagonists
|
814 Participants
n=93 Participants
|
|
Anticoagulation
Non effective Vitamin K antagonists
|
245 Participants
n=93 Participants
|
|
Anticoagulation
Other
|
14 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 48 hours before ablationOutcome measures
| Measure |
Atrial Fibrillation
n=2494 Participants
D-dimer assay before ablation of atrial fibrillation
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement
|
No Atrial Thrombus
Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography
|
|---|---|---|
|
Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
|
48 Participants
|
—
|
SECONDARY outcome
Timeframe: 48 hours before ablationCHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)
Outcome measures
| Measure |
Atrial Fibrillation
n=48 Participants
D-dimer assay before ablation of atrial fibrillation
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement
|
No Atrial Thrombus
n=2446 Participants
Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography
|
|---|---|---|
|
CHADS2 Score
CHADS2 score = 0
|
5 Participants
|
1277 Participants
|
|
CHADS2 Score
CHADS2 score = 1
|
20 Participants
|
744 Participants
|
|
CHADS2 Score
CHADS2 score = 2
|
13 Participants
|
299 Participants
|
|
CHADS2 Score
CHADS2 score ≥ 3
|
10 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: 48 hours before ablationvariables related to the presence of atrial thrombus
Outcome measures
| Measure |
Atrial Fibrillation
n=48 Participants
D-dimer assay before ablation of atrial fibrillation
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement
|
No Atrial Thrombus
n=2446 Participants
Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography
|
|---|---|---|
|
Risk Factors
Age (≥ 75yrs)
|
8 Participants
|
148 Participants
|
|
Risk Factors
Female gender
|
15 Participants
|
661 Participants
|
|
Risk Factors
Persistent fibrillation
|
28 Participants
|
968 Participants
|
|
Risk Factors
Hypertension
|
30 Participants
|
886 Participants
|
|
Risk Factors
Diabetes mellitus
|
9 Participants
|
218 Participants
|
|
Risk Factors
Heart failure
|
19 Participants
|
285 Participants
|
|
Risk Factors
History of stroke
|
6 Participants
|
109 Participants
|
|
Risk Factors
Previous left atrial ablation
|
9 Participants
|
584 Participants
|
|
Risk Factors
Anticoagulation prior to ablation
|
47 Participants
|
2212 Participants
|
SECONDARY outcome
Timeframe: 48 hours before ablationThe 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
Outcome measures
| Measure |
Atrial Fibrillation
n=48 Participants
D-dimer assay before ablation of atrial fibrillation
D-dimer assay before ablation of atrial fibrillation: Blood sample collection for D-dimers measurement
|
No Atrial Thrombus
n=2446 Participants
Patients with no atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography
|
|---|---|---|
|
Atrial Thrombus Exclusion (ATE) Score
ATE score = 0
|
0 Participants
|
911 Participants
|
|
Atrial Thrombus Exclusion (ATE) Score
ATE score = 1
|
23 Participants
|
965 Participants
|
|
Atrial Thrombus Exclusion (ATE) Score
ATE score = 2
|
14 Participants
|
467 Participants
|
|
Atrial Thrombus Exclusion (ATE) Score
ATE score = 3
|
10 Participants
|
101 Participants
|
|
Atrial Thrombus Exclusion (ATE) Score
ATE score = 4
|
1 Participants
|
2 Participants
|
Adverse Events
Atrial Fibrillation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Antoine Milhem
Groupe Hospitalier de la Rochelle Ré Aunis
Phone: +33546455050
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place