Physician Acceptance of the NeuTrace System for Cardiac Electroanatomic Mapping

NCT05214170 | Unknown DMC

• 1 other identifier: NT001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter

Keywords

Cardiac Arrhythmias; Atrial Fibrillation; Atrial Flutter; Electroanatomic Mapping

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately post-procedure

Secondary Outcomes (7)

• Physician rating of catheter visibility during electroanatomic mapping with NeuTrace System via a questionnaire

  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

  Immediately post-procedure

• Measurement of the shift in the electroanatomic during the procedure with the NeuTrace System

  Immediately post-procedure

• Measurement of the drift in the electroanatomic during the procedure with the NeuTrace System

  Immediately post-procedure

• Physician rating of the manual annotation of ablation points with the NeuTrace System via a questionnaire

  Immediately post-procedure

Study Arms (1)

Electroanatomic mapping with NeuTrace System

EXPERIMENTAL

Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.

Device: Electroanatomic mapping with the NeuTrace System

Interventions

Electroanatomic mapping with the NeuTrace System DEVICE

Patients with arrhythmias undergo electroanatomic mapping with the NeuTrace System.

Electroanatomic mapping with NeuTrace System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NeuTrace, Inc.: lead

Study Sites (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gediminas Rackauskas, MD

  Vilnius University Hospital Santaros Klinikos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pradeep S Rajendran, MD/PhD

CONTACT

6303061864; prajendran@neucures.com

Animesh Agarwal, BS, MBA

CONTACT

2679453387; animesh@neucures.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, single-arm trial

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 28, 2022
• Study Start: June 7, 2021
• Primary Completion: May 7, 2024
• Study Completion: June 7, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)