Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping

NeuTrace

Status: Enrolling

Conditions: Atrial Flutter; Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: Electroanatomic mapping with the NeuTrace System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05214170

NT001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Electroanatomic mapping with NeuTrace System

Experimental group

Description:

Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.

Treatment:

Device: Electroanatomic mapping with the NeuTrace System