Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire |
At the completion of each electrophysiology study, the principal investigator will be asked to complete a questionnaire in which he or she qualitatively rates the electroanatomic map created by the NeuTrace System on a numeric scale from 1 to 5 (1 = not satisfied, 5 = very satisfied). |
Immediately post-procedure |
|
Secondary |
Physician rating of catheter visibility during electroanatomic mapping with NeuTrace System via a questionnaire |
At the completion of each electrophysiology study, the principal investigator will be asked to complete a questionnaire in which he or she qualitatively rates the visibility of the catheter during electroanatomic mapping with the NeuTrace System on a numeric scale from 1 to 5 (1 = not satisfied, 5 = very satisfied). |
Immediately post-procedure |
|
Secondary |
Physician rating of the accuracy of the anatomical map created with the NeuTrace System compared to an image obtained via computerized tomography, magnetic resonance imaging, or intracardiac echocardiography via a questionnaire |
Each participant will have an image obtained of their heart either pre-procedurally via computed tomography or magnetic resonance imaging, or intraprocedurally via intracardiac echocardiography. At the completion of each electrophysiology study, the principal investigator will be asked to complete a questionnaire in which he or she qualitatively rates the accuracy of the electroanatomic map created by the NeuTrace System with the image of the heart obtained via computerized tomography, magnetic resonance imaging, or intracardiac echocardiography. |
Immediately post-procedure |
|
Secondary |
Measurement of the shift in the electroanatomic during the procedure with the NeuTrace System |
Shift refers to the movement of an electroanatomic map during the procedure (e.g., the patient moves in relation to the magnetic field). During each electrophysiology study, the principal investigator will annotate a point on the electroanatomic map with the NeuTrace System (X at time 1). The principal investigator will return to and again annotate that same point on the electroanatomic map 20 minutes later (X at time 2). The location of the point will be confirmed via intracardiac echocardiography. The distance between the points (X at time 1 and X at time 2) will be measured on the NeuTrace System in millimeters. |
Immediately post-procedure |
|
Secondary |
Measurement of the drift in the electroanatomic during the procedure with the NeuTrace System |
Drift refers to the movement of an electroanatomic map during the procedure due to interference with the magnetic field. During each electrophysiology study, the principal investigator will annotate a point on the electroanatomic map with the NeuTrace System (X1). The principal investigator will then move the X-ray image intensifier (a common source of interference) to a fixed interval above the magnetic field generator and again annotate that same point on the electroanatomic map (X2). The distance between the points (X1 and X2) will be measured on the NeuTrace System in millimeters. |
Immediately post-procedure |
|
Secondary |
Physician rating of the manual annotation of ablation points with the NeuTrace System via a questionnaire |
At the completion of each electrophysiology study, the principal investigator will be asked to complete a questionnaire in which he or she qualitatively rates the manual annotation of ablations points during electroanatomic mapping with the NeuTrace System on a numeric scale from 1 to 5 (1 = not satisfied, 5 = very satisfied). |
Immediately post-procedure |
|
Secondary |
Physician rating of the total mapping time with the NeuTrace System via a questionnaire |
Total mapping time refers to the time taken to create an electroanatomic map. At the completion of each electrophysiology study, the principal investigator will be asked to complete a questionnaire in which he or she qualitatively rates the total mapping time with the NeuTrace System on a numeric scale from 1 to 5 (1 = not satisfied, 5 = very satisfied). |
Immediately post-procedure |
|
Secondary |
Number of participants with serious adverse events at 30-day post-procedure telephone follow up |
Each participant will have a telephone follow-up at 30 days post-procedure for monitoring of serious adverse events. The number of participants with a serious adverse events will be measured. |
30 days post-procedure |
|