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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.
Full 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 of paired recordings from the same patient, in sinus rhythm or during episodes of symptomatic non-life-threatening arrhythmia. The study will provide the necessary data for an FDA 510(k) regulatory submission and develop experience for market access and integration into clinical workflows.
Enrollment
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Volunteers
Inclusion criteria
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:
Able and willing to sign informed consent.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
198 participants in 1 patient group
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Central trial contact
Pooja Chatterjee
Data sourced from clinicaltrials.gov
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