Health Condition 1: I489- Unspecified atrial fibrillation and atrial flutter
Conditions
Interventions
Control Intervention1: 12-Lead ECG: All used for screening patients for their ECG patterns (30-seconds,twice) and simultaneously, with 2-devices at a time. One sub-group of patients that need 24-hour
Sponsors
Fourth Frontier Technologies Pvt. Ltd., (FFTPL)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: Adults ( > 18 years of age), both genders 2. Subjects presenting in the Outpatient department(OPD) with a known case of AF and/or patients admitted as Inpatients for AF by their treating cardiologist with an indication for a 12-Lead ECG or 24-hour ECG Holter monitoring. 3. Subjects presenting in the Outpatient department (OPD) with no known AF and/or patients with suspicious arrhythmic episodes were admitted as Out-/In-patients by their treating cardiologist with an indication for a 12-Lead ECG or 24-hour ECG Holter monitoring.
Exclusion criteria
Exclusion criteria: 1. Subjects with a critical underlying cardiac problem. 2. Subjects on a ventilator or any other kind of life support system. 3. Subjects assessed to be in a serious or life-threatening situation due to any cause. 4. Subject with a chest deformity or skin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validate the reliability of Frontier X Plus (FX+) to produce a clinically equivalent waveform in agreement to a gold-standard 12-lead ECG’s Lead-1 reference by comparing a. Quantitative analysis of R-R intervals of FX+ versus 12-lead ECG b. Qualified cardiologist performs naked-eye review and comparison of date and time-matched ECG waveform segments from FX+ versus 12-lead ECG. Evaluate the Sensitivity and Specificity of the AF detection by Frontier X Plus (FX+) a. Comparative analysis of 2 separate 30-second SPOT rhythm analysis for AF detection obtained simultaneously from FX+ along with the gold standard 12-lead ECG followed by 2 separate 30-second recordings from FX+ and a US FDA-cleared wearable, Kardia Monitor (KM) AliveCor (cleared to display and detect AF and normal sinus rhythm) worn simultaneously. b. Comparative 24-hour CONTINUOUS Rhythm analysis for AF detection obtained simultaneously from FX+ and gold-standard 12-channel ECG Holter.Timepoint: 30 seconds - spot checks 24 hour - continuous checks | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the sensitivity and specificity of detecting, Normal Sinus Rhythm, Sinus Tachycardia, Sinus Bradycardia, other rhythms and noisy signals/inconclusive/unreadable from all the ECG recordings obtained both on SPOT check and CONTINUOUS monitoring (using techniques mentioned in primary outcome #2, above.)Timepoint: 30 seconds - spot checks 24 hour - continuous checks | — |
Countries
India
Contacts
Public ContactDr Sathish S Reddy
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Outcome results
None listed