CClinicalTrials.gg
CompletedNCT05181878Updated Nov 13, 2023

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

An observational study in Catheter Ablation, sponsored by Acutus Medical. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.

Sponsored by Acutus Medical · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
8
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Catheter Ablation

Keywords

  • localization
03

In context

Lead sponsor

Acutus Medical is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Any participant 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap 2.1 System.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. In the opinion of the investigator, any contraindication to the planned ablation, including anticoagulation contraindications, atrial thrombus, renal failure, or sepsis.
  2. Current enrollment in any study protocol sponsored by Acutus Medical
  3. 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.).
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
8 participants (actual)
Patient registry
No

Interventions

  • DeviceThe AcQMap 2.1 System with Electro-Magnetic Tracking Feasibility System

    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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: Procedure

07

Study locations

2 sites
  • Kansas City Heart Rhythm Institute
    Overland Park, Kansas 66211, United States
  • Nevada Heart and Vascular
    Las Vegas, Nevada 89118, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05181878
Lead sponsor
Acutus Medical
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Dec 29, 2021
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Nov 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion