Suspended

Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping

What is being tested

Electroanatomic mapping with the NeuTrace System

Device

Who is being recruted

Arrhythmias, Cardiac+4

+ Atrial Fibrillation

+ Atrial Flutter

From 18 to 80 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Device Feasibility Study

Interventional

Study Start: June 2021

See protocol details

Summary

Principal SponsorNeuTrace, Inc.

Study ContactPradeep S Rajendran, MD/PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 7, 2021

Actual date on which the first participant was enrolled.

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.

Official TitlePhysician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping

NCT05214170

Principal SponsorNeuTrace, Inc.

Study ContactPradeep S Rajendran, MD/PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Device Feasibility Study

These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arrhythmias, CardiacAtrial FibrillationAtrial FlutterCardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate

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

11 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Vilnius University Hospital Santaros Klinikos

Vilnius, LithuaniaOpen Vilnius University Hospital Santaros Klinikos in Google Maps

SuspendedOne Study Center