Trial Outcomes & Findings for Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography (NCT NCT02213666)
NCT ID: NCT02213666
Last Updated: 2017-05-03
Results Overview
The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.
COMPLETED
72 participants
Time of Clinical Procedure Only (Average 6 hours)
2017-05-03
Participant Flow
Patients were interviewed in the pre-procedure room on the day of the planned procedure after consenting for the planned clinical procedure. A Co-Investigator introduced and discussed the study with the patient in detail, provided the consent form to review and addressed any questions.
Participant milestones
| Measure |
Intracardiac and Transesophageal Echocardiography
The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
|
|---|---|
|
Overall Study
STARTED
|
72
|
|
Overall Study
COMPLETED
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Intracardiac and Transesophageal Echocardiography
The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography
Baseline characteristics by cohort
| Measure |
Enrolled Patients
n=72 Participants
The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time of Clinical Procedure Only (Average 6 hours)The right atrial appendage (RAA) and left atrial appendage (LAA) will be assessed for the presence or absence of intracardiac thrombi with the Siemens AcuNav Ultrasound catheter. This is also performed with the standard of care modality, transesophageal echocardiography (TEE) with both operators blinded to the opposing imaging modality. The presence of LAA thrombi requires cancellation of the clinical procedure. After a determination has been made by both operators regarding the presence or absence of thrombi will investigators be unblinded to the opposing imaging modality result. If intracardiac thrombi was detected, the procedure was cancelled according to standard clinical guidelines and practice. There is no follow-up data collected. Participants were followed during enrollment and the clinical ablation procedure which is an average of a 6 hour period.
Outcome measures
| Measure |
Enrolled Patients
n=71 Participants
The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
|
|---|---|
|
Intracardiac and Transesophageal Echo Results
Intracardiac Echo Completed
|
71 participants
|
|
Intracardiac and Transesophageal Echo Results
TEE Completed
|
69 participants
|
|
Intracardiac and Transesophageal Echo Results
Total Cases of Definite Thrombi Identified
|
4 participants
|
|
Intracardiac and Transesophageal Echo Results
TEE Diagnostic in Identification of Thrombi
|
1 participants
|
|
Intracardiac and Transesophageal Echo Results
ICE Diagnostic in Identification of Thrombi
|
4 participants
|
Adverse Events
Enrolled Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enrolled Patients
n=71 participants at risk
The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
|
|---|---|
|
Surgical and medical procedures
Oropharyngeal bleeding from TEE
|
2.8%
2/71 • Number of events 2 • During enrollment, the clinical ablation procedure, while in the hospital.
All patients were screened for any complications at the conclusion of the clinical procedure (average of 6 hour period).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place