Clinical trial NCT05214170: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmias, Cardiac
Atrial Fibrillation
Atrial Flutter
Keywords: Cardiac Arrhythmias
Atrial Fibrillation
Atrial Flutter
Electroanatomic Mapping
Lead sponsor: NeuTrace, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, single-arm trial
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: Physician rating of the electroanatomic map created by the NeuTrace System via a questionnaire
timeFrame: Immediately post-procedure
Secondary outcomes:
measure: Physician rating of catheter visibility during electroanatomic mapping with NeuTrace System via a questionnaire
timeFrame: Immediately post-procedure
measure: 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
timeFrame: Immediately post-procedure
measure: Measurement of the shift in the electroanatomic during the procedure with the NeuTrace System
timeFrame: Immediately post-procedure
measure: Measurement of the drift in the electroanatomic during the procedure with the NeuTrace System
timeFrame: Immediately post-procedure
measure: Physician rating of the manual annotation of ablation points with the NeuTrace System via a questionnaire
timeFrame: Immediately post-procedure
measure: Physician rating of the total mapping time with the NeuTrace System via a questionnaire
timeFrame: Immediately post-procedure
measure: Number of participants with serious adverse events at 30-day post-procedure telephone follow up
timeFrame: 30 days post-procedure
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
Study officials:
affiliation: Vilnius University Hospital Santaros Klinikos
name: Gediminas Rackauskas, MD
role: PRINCIPAL_INVESTIGATOR
References: