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

Completed

• Conditions: Catheter Ablation

• Registration Number: NCT05181878
• Lead Sponsor: Acutus Medical

Brief 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.

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.

Study Timeline

• Study First Submitted: 2021-12-08
• Study Start: 2021-12-29
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-09
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful recording of continuous and synchronized impedance and magnetic localization information.	Procedure	Successful recording of continuous and synchronized impedance and magnetic localization information.

Trial Locations

Locations (2)

Nevada Heart and Vascular; 🇺🇸 Las Vegas, Nevada, United States

Kansas City Heart Rhythm Institute; 🇺🇸 Overland Park, Kansas, United States