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

NCT05181878 | Completed FDA Device

• 2 other identifiers: CLP-24 USCLP-24 (EU)
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Catheter Ablation

Keywords

localization

Outcome Measures

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.

  Procedure

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Acutus Medical: lead

Study Sites (2)

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Nevada Heart and Vascular

Las Vegas, Nevada, 89118, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 6, 2022
• Study Start: December 29, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Locations

US (2)