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

Completed

Conditions studied: Catheter Ablation

In brief

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.

Key facts

Study ID

NCT05181878

Run by

Acutus Medical

People needed

8

Starts

2021-12-29

Expected to finish

2023-06-30

Last updated by the study team

2023-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.).

Where it is running

• Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States
• Nevada Heart and Vascular — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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