An interventional study of Electroanatomic mapping with the NeuTrace System in Arrhythmias, Cardiac, Atrial Fibrillation and Atrial Flutter, sponsored by NeuTrace, Inc.. Status unknown at 1 site in Lithuania. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by NeuTrace, Inc. · Not applicable, Interventional, and Device feasibility
The trial is a prospective, non-randomized, single-arm feasibility trial to evaluate physician acceptance of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
Arrhythmias, or abnormal heart rhythms, are a major cause of morbidity and mortality worldwide. In patients with arrhythmias, electrophysiology (EP) studies are often performed to assess the electrical system of the heart. Since its introduction in the 1990s, electroanatomic mapping has become a cornerstone of EP studies. Electroanatomic mapping systems allow for non-fluoroscopic navigation of the heart and the creation of three-dimensional (3D) anatomic and electroanatomic maps. These maps facilitate diagnosing and treating arrhythmias.
The NeuTrace System is a cardiac EP mapping system that is intended to be used during catheter-based atrial and ventricular mapping procedures. The system is designed to acquire and analyze data points and use this information to display 3D anatomical and electroanatomic mapping of the human heart. The system is used with a compatible, marketed magnetic sensor-enabled catheter and compatible EP recording system to acquire the location information and local electrogram needed to create the cardiac maps. The purpose of the trial is to evaluate physician acceptance and feasibility of the NeuTrace System v1.0 for cardiac electroanatomic mapping.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 20 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with NeuTrace, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.
Device: Electroanatomic mapping with the NeuTrace System
Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.
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).
Time frame: Immediately post-procedure
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).
Time frame: Immediately post-procedure
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.
Time frame: Immediately post-procedure
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.
Time frame: Immediately post-procedure
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.
Time frame: Immediately post-procedure
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).
Time frame: Immediately post-procedure
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).
Time frame: Immediately post-procedure
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.
Time frame: 30 days post-procedure
Plan to share: No
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