Trial Outcomes & Findings for Exclusion of Intra-atrial Thrombus Before Catheter Ablation (NCT NCT03455673)
NCT ID: NCT03455673
Last Updated: 2023-12-22
Results Overview
Patients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, without hypertension, heart failure, history of stroke and a plasma d-dimer level \< 270 ng/ml ATE : Atrial Thrombus Exclusion minimum value = 0 maximum value = 4, patient at higher risk of atrial thrombus
Recruitment status
COMPLETED
Target enrollment
3160 participants
Primary outcome timeframe
at most 48 hours before ablation
Results posted on
2023-12-22
Participant Flow
Participant milestones
| Measure |
Atrial Fibrillation
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Overall Study
STARTED
|
3160
|
|
Overall Study
Patients With an ATE Score
|
3099
|
|
Overall Study
COMPLETED
|
3072
|
|
Overall Study
NOT COMPLETED
|
88
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Atrial Fibrillation
n=3072 Participants
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3072 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1422 Participants
n=3072 Participants
|
|
Age, Categorical
>=65 years
|
1650 Participants
n=3072 Participants
|
|
Age, Continuous
|
66 years
n=3072 Participants
|
|
Sex: Female, Male
Female
|
863 Participants
n=3072 Participants
|
|
Sex: Female, Male
Male
|
2209 Participants
n=3072 Participants
|
|
Region of Enrollment
France
|
2996 participants
n=3072 Participants
|
|
Region of Enrollment
Switzerland
|
76 participants
n=3072 Participants
|
|
Clinical history of heart failure
|
459 Participants
n=3072 Participants
|
|
Clinical history of stroke or transient ischemic attack
|
175 Participants
n=3072 Participants
|
|
Hypertension
|
1292 Participants
n=3072 Participants
|
|
Diabetes mellitus
|
350 Participants
n=3072 Participants
|
|
Vascular disease
|
376 Participants
n=3072 Participants
|
|
CHA2DS2VASc score
|
2 units on a scale
n=3072 Participants
|
|
CHADS2 score
|
1 units on a scale
n=3072 Participants
|
|
Diagnosis
Left atrial tachycardia
|
308 Participants
n=3072 Participants
|
|
Diagnosis
Paroxysmal fibrillation
|
1638 Participants
n=3072 Participants
|
|
Diagnosis
Persistent fibrillation
|
1126 Participants
n=3072 Participants
|
PRIMARY outcome
Timeframe: at most 48 hours before ablationPatients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, without hypertension, heart failure, history of stroke and a plasma d-dimer level \< 270 ng/ml ATE : Atrial Thrombus Exclusion minimum value = 0 maximum value = 4, patient at higher risk of atrial thrombus
Outcome measures
| Measure |
Atrial Fibrillation
n=3072 Participants
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Number of Patients With Atrial Thrombus and a Zero ATE Score
ATE = 0, thrombus
|
2 Participants
|
|
Number of Patients With Atrial Thrombus and a Zero ATE Score
ATE = 0, No thrombus
|
816 Participants
|
|
Number of Patients With Atrial Thrombus and a Zero ATE Score
ATE > 0, thrombus
|
27 Participants
|
|
Number of Patients With Atrial Thrombus and a Zero ATE Score
ATE > 0, No thrombus
|
2227 Participants
|
SECONDARY outcome
Timeframe: at most 48 hours before ablationPatients with atrial thrombus diagnosed by pre-procedural transoesophageal
Outcome measures
| Measure |
Atrial Fibrillation
n=3072 Participants
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Number of Patients With Atrial Thrombus
Thrombus diagnosed by the reference method
|
29 Participants
|
|
Number of Patients With Atrial Thrombus
No thrombus diagnosed by the reference method
|
3043 Participants
|
SECONDARY outcome
Timeframe: at most 48 hours before ablationPatients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, vascular disease \[previous myocardial infarction, peripheral arterial disease or aortic plaque\], history of stroke or transient ischemic attack, aged under 75, and male minimum value = 0 maximum value = 10, at most risk of stroke
Outcome measures
| Measure |
Atrial Fibrillation
n=3072 Participants
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
CHADS2VASC = 0, no thrombus
|
604 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
CHADS2VASC = 0, thrombus
|
3 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
CHADS2VASC > 0, thrombus
|
26 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
CHADS2VASC > 0, no thrombus
|
2438 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2VASC Score
CHADS2VASC score unavailable
|
1 Participants
|
SECONDARY outcome
Timeframe: at most 48 hours before ablationPatients with atrial thrombus diagnosed by pre-procedural transoesophageal echocardiography, and without congestive heart failure, hypertension, diabetes mellitus, history of stroke or transient ischemic attack, and aged under 75 minimum value = 0 maximum value = 6, at most risk of stroke
Outcome measures
| Measure |
Atrial Fibrillation
n=3072 Participants
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
CHADS2 = 0, thrombus
|
4 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
CHADS2 = 0, no thrombus
|
1285 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
CHADS2 > 0, thrombus
|
25 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
CHADS2 > 0, no thrombus
|
1757 Participants
|
|
Number of Patients With Atrial Thrombus Among Patients With a Zero CHADS2 Score
CHADS2 score unavailable
|
1 Participants
|
Adverse Events
Atrial Fibrillation
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Atrial Fibrillation
n=3072 participants at risk
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3072 • Number of events 1 • The study lasted 48 hours for each participant. Adverse events were collected during these 48 hours.
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.03%
1/3072 • Number of events 1 • The study lasted 48 hours for each participant. Adverse events were collected during these 48 hours.
|
Other adverse events
| Measure |
Atrial Fibrillation
n=3072 participants at risk
ATE score will be determined for patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia
ATE score: The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (\> 270 ng/ml) = 1
|
|---|---|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3072 • Number of events 1 • The study lasted 48 hours for each participant. Adverse events were collected during these 48 hours.
|
Additional Information
Caroline Allix-Béguec, manager of clinical trials
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