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NCT05181878 Clinical Trial

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

Catheter Ablation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05181878
Other study ID # CLP-24 US
Secondary ID CLP-24 (EU)
Status Completed
Phase
First received
Last updated
Start date December 29, 2021
Est. completion date June 30, 2023

Study information
Verified date November 2023
Source Acutus Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 8
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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: 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.).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• The 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.

Locations
Country Name City State
United States Nevada Heart and Vascular Las Vegas Nevada
United States Kansas City Heart Rhythm Institute Overland Park Kansas

Sponsors (1)
Lead Sponsor Collaborator
Acutus Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful recording of continuous and synchronized impedance and magnetic localization information. Successful recording of continuous and synchronized impedance and magnetic localization information. Procedure
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