Status:
COMPLETED
AIMIGo 12L ECG Synthesis Software Pivotal Study for Arrythmia Detection
Lead Sponsor:
HeartBeam, Inc.
Conditions:
Arrhythmias, Cardiac
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a prospective single-arm multicenter clinical trial. Adult patients will be consented and enrolled in an outpatient cardiology office or Arrhythmia Clinics.
Detailed Description
The purpose of this study is to conduct clinical validation of the AIMIGo 12-lead Synthesis Software against a standard FDA-cleared 12-lead ECG system, based on quantitative and qualitative assessment...
Eligibility Criteria
Inclusion
- Male or female subjects over 18 years of age.
- Referred to outpatient arrhythmia clinic with a history of one or more of the following conditions:
- Previous diagnosis of arrhythmia presenting to the clinic for routine follow-up evaluation.
- Patients with symptoms indicative of cardiac arrhythmias.
- Able and willing to sign informed consent.
Exclusion
- Open chest wounds or recent (\<30 days) surgery to the chest or abdomen.
- Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol.
Key Trial Info
Start Date :
March 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT06123130
Start Date
March 13 2024
End Date
June 20 2024
Last Update
July 5 2024
Active Locations (5)
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1
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
2
Atlanta Heart Specialists
Tucker, Georgia, United States, 30084
3
The Mount Sinai Hospital
New York, New York, United States, 10029
4
Long Island Jewish Medical Center
Queens, New York, United States, 11040