Back to resultsPhysician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
Primary Purpose
Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
Status
Recruiting
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Electroanatomic mapping with the NeuTrace System
Sponsored by
About this trial
This is an interventional device feasibility trial for Arrhythmias, Cardiac focused on measuring Cardiac Arrhythmias, Atrial Fibrillation, Atrial Flutter, Electroanatomic Mapping
Eligibility Criteria
Inclusion Criteria:
- Patient with standard indications for an electrophysiology study and/or catheter ablation per European Heart Rhythm Association/Heart Rhythm Society) guidelines and/or judgement of the investigator
- Age 18 to 80
- Signed Informed Consent Form
Exclusion Criteria:
- Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/percutaneous transluminal coronary angioplasty, or coronary artery stenting which occurred during the 90-day interval preceding the date that participant signed the Informed Consent Form
- Unstable angina
- NHYA class III or IV congestive heart failure and/or known left ventricular ejection fraction less than 45%
- Thrombocytosis, thrombocytopenia
- Contraindication to anticoagulation therapy
- Active systemic infection
- Cryoglobulinemia
- Known reversible causes of arrhythmia
- Any cerebral ischemic event (stroke or transient ischemic attacks) which occurred during the 180-day interval preceding the date the participant signed the Informed Consent Form, or any known unresolved complications from the previous stroke/transient ischemic attack
- Pregnancy
- Unwilling or unable to comply fully with study procedures
Sites / Locations
- Vilnius University Hospital Santaros KlinikosRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electroanatomic mapping with NeuTrace System
Arm Description
Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
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.
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).
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05214170
Brief Title
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
Official Title
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
May 7, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuTrace, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
Keywords
Cardiac Arrhythmias, Atrial Fibrillation, Atrial Flutter, Electroanatomic Mapping
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, non-randomized, single-arm trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electroanatomic mapping with NeuTrace System
Arm Type
Experimental
Arm Description
Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.
Intervention Type
Device
Intervention Name(s)
Electroanatomic mapping with the NeuTrace System
Intervention Description
Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.
Primary Outcome Measure Information:
Title
Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Physician rating of catheter visibility during electroanatomic mapping with NeuTrace System via a questionnaire
Description
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
Title
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
Description
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
Title
Measurement of the shift in the electroanatomic during the procedure with the NeuTrace System
Description
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
Title
Measurement of the drift in the electroanatomic during the procedure with the NeuTrace System
Description
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
Title
Physician rating of the manual annotation of ablation points with the NeuTrace System via a questionnaire
Description
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
Title
Physician rating of the total mapping time with the NeuTrace System via a questionnaire
Description
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
Title
Number of participants with serious adverse events at 30-day post-procedure telephone follow up
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with standard indications for an electrophysiology study and/or catheter ablation per European Heart Rhythm Association/Heart Rhythm Society) guidelines and/or judgement of the investigator
Age 18 to 80
Signed Informed Consent Form
Exclusion Criteria:
Any cardiac surgery, myocardial infarction, percutaneous coronary intervention/percutaneous transluminal coronary angioplasty, or coronary artery stenting which occurred during the 90-day interval preceding the date that participant signed the Informed Consent Form
Unstable angina
NHYA class III or IV congestive heart failure and/or known left ventricular ejection fraction less than 45%
Thrombocytosis, thrombocytopenia
Contraindication to anticoagulation therapy
Active systemic infection
Cryoglobulinemia
Known reversible causes of arrhythmia
Any cerebral ischemic event (stroke or transient ischemic attacks) which occurred during the 180-day interval preceding the date the participant signed the Informed Consent Form, or any known unresolved complications from the previous stroke/transient ischemic attack
Pregnancy
Unwilling or unable to comply fully with study procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pradeep S Rajendran, MD/PhD
Phone
6303061864
Email
prajendran@neucures.com
First Name & Middle Initial & Last Name or Official Title & Degree
Animesh Agarwal, BS, MBA
Phone
2679453387
Email
animesh@neucures.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gediminas Rackauskas, MD
Organizational Affiliation
Vilnius University Hospital Santaros Klinikos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University Hospital Santaros Klinikos
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gediminas Rackauskas, MD
Email
Gediminas.Rackauskas@santa.lt
First Name & Middle Initial & Last Name & Degree
Kristina Scerbakovaite
Email
kristina.scerbakovaite@santa.lt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
We'll reach out to this number within 24 hrs