Arrhythmias, CardiacNCT05214170
Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
A study testing Electroanatomic mapping with the NeuTrace System in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by NeuTrace, Inc. at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Electroanatomic mapping with the NeuTrace System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteLithuania
- Study dates
- 7 Jun 2021to 7 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Lithuania1 site, 1 recruiting
- Recruiting
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
Gediminas Rackauskas, MD, Gediminas.Rackauskas@santa.lt
Kristina Scerbakovaite, kristina.scerbakovaite@santa.lt
About this study
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.
Read the 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.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- Being tested
- Electroanatomic mapping with the NeuTrace System
- Keywords
- Cardiac Arrhythmias, Atrial Fibrillation, Atrial Flutter, Electroanatomic Mapping
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroanatomic mapping with the NeuTrace SystemDevice
Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.
| Study group | Role | What they receive |
|---|---|---|
| Electroanatomic mapping with NeuTrace System | Experimental | Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System. Receives: Device: Electroanatomic mapping with the NeuTrace System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately post-procedure
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start7 Jun 2021
- Primary completion7 May 2024 (estimated)
- Study completion7 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomized, single-arm trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeuTrace, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gediminas Rackauskas, MD, Principal investigator, Vilnius University Hospital Santaros Klinikos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214170
- Sponsor's protocol ID
- NT001
- Status last verified
- Apr 2023
- First submitted
- 13 Dec 2021
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping
- ClinicalTrials.gov ID
- NCT05214170
- Acronym / sponsor ID
- NT001
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- Keywords
- Cardiac Arrhythmias, Atrial Fibrillation, Atrial Flutter, Electroanatomic Mapping
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NeuTrace, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 7 May 2024 (estimated)
- Study completion
- 7 Jun 2024 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomized, single-arm trial
| Arm | Type | Receives |
|---|---|---|
| Electroanatomic mapping with NeuTrace System | Experimental | Device: Electroanatomic mapping with the NeuTrace SystemPatients with arrhythmias undergo electroanatomic mapping with the NeuTrace System. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroanatomic mapping with the NeuTrace SystemPatients with arrhythmias undergo electroanatomic mapping with the NeuTrace System. | Device | Electroanatomic mapping with NeuTrace System |
Primary outcome
Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire
Time frame: Immediately post-procedure
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).
7 secondary outcomes
Physician rating of catheter visibility during electroanatomic mapping with NeuTrace System via a questionnaire
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
Time frame: Immediately post-procedure
Measurement of the shift in the electroanatomic during the procedure with the NeuTrace System
Time frame: Immediately post-procedure
Measurement of the drift in the electroanatomic during the procedure with the NeuTrace System
Time frame: Immediately post-procedure
Physician rating of the manual annotation of ablation points with the NeuTrace System via a questionnaire
Time frame: Immediately post-procedure
Physician rating of the total mapping time with the NeuTrace System via a questionnaire
Time frame: Immediately post-procedure
Number of participants with serious adverse events at 30-day post-procedure telephone follow up
Time frame: 30 days post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Arrhythmias, Cardiac
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gediminas Rackauskas, MD principal investigator
Vilnius University Hospital Santaros Klinikos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroanatomic mapping with the NeuTrace System in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by NeuTrace, Inc. at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pradeep S Rajendran, MD/PhD (6303061864, prajendran@neucures.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire (time frame: Immediately post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.