Design and Rationale of the Assessment of the Mindmics Recording System to Collect Data to Facilitate the Development of an Algorithm to Discriminate Atrial Fibrillation From Sinus Rhythm

Introduction:

This study will evaluate the efficacy of the MindMics earbud recording apparatus to record data from patients with known atrial fibrillation as well as those in sinus rhythm. Patients in the clinic and patients with atrial fibrillation scheduled to undergo elective direct-current cardioversion will be the chosen subjects. This process will select a variety of patients to allow evaluation of the Mindmics apparatus's ability to collect data from patients with normal as well as abnormal cardiac rhythms.

Hypotheses

The MindMics earbud device is capable of recording normal cardiac rhythms in patients noninvasively using earbud device in a noninvasive manner. The same apparatus may be capable of discerning atrial fibrillation compared with normal sinus rhythm. This will be evaluated by collecting information from patients with atrial fibrillation in the office as well as those scheduled to undergo an elective direct-current cardioversion procedure. A timed recording of the clinical rhythm while wearing the apparatus will allow simultaneous recording of data from an ECG recording (documenting the patient's clinical arrhythmia) at the same time the MindMics earbud records its data obtained during the ECG recording of the patient's rhythm. For those patient scheduled for direct current cardioversion, the patient will undergo the direct-current cardioversion and a second recording will be obtained during sinus rhythm afterwards allowing an appropriate comparison of the differences in the recording sets.

The objective is to demonstrate differences between recordings made in atrial fibrillation and those in sinus rhythm that can be used to develop an algorithm allow discernment between atrial fibrillation and sinus rhythm.