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Completed

NCT Number: NCT05181878

AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)

Non-Significant Risk Clinical Study

Clinical Investigational Use Only for the purposes of collecting electromagnetic tracking data to validate the use of the device in a clinical setting.

Completed

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kansas City Heart Rhythm Institute, Overland Park, Kansas, United States

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About this study

The EMT Feasibility Study is a prospective, multi-center, feasibility study designed to demonstrate the feasibility of EMT solution in conjunction with the AcQMap 2.1 System's existing capabilities.

The objective of the study is to demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female 18 years of age or older.
  • Currently scheduled for the ablation of an atrial arrhythmia utilizing the diagnostic AcQMap 2.1 System.
  • Willing and able to give written informed consent.

Exclusion criteria

  • In the opinion of the investigator, any contraindication to the planned ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
  • Current enrollment in any study protocol sponsored by Acutus Medical
  • Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

Treatment and study plan

The AcQMap 2.1 System with Electro-Magnetic Tracking Feasibility System

Device

Demonstrate the ability of the AcQMap 2.1 System to support EMT in conjunction with the existing impedance localization capabilities. The new EMT technology is expected to continuously provide fully synchronized and similar localization information to the impedance-based localization information associated with the location of the catheter's magnetic sensor position.

Primary outcomes

  1. Successful recording of continuous and synchronized impedance and magnetic localization information.

    Time frame: Procedure

    Successful recording of continuous and synchronized impedance and magnetic localization information.

Sponsors and collaborators

Lead sponsor

Acutus Medical

Industry

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 6, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.