Status:
COMPLETED
AcQMap 2.1 With Electro-Magnetic Tracking System Feasibility Study (EMT Feasibility Study)
Lead Sponsor:
Acutus Medical
Conditions:
Catheter Ablation
Eligibility:
All Genders
18+ years
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.).
Key Trial Info
Start Date :
December 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05181878
Start Date
December 29 2021
End Date
June 30 2023
Last Update
November 13 2023
Active Locations (2)
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1
Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States, 66211
2
Nevada Heart and Vascular
Las Vegas, Nevada, United States, 89118