Heartbeat Sensitivity Calibration Using the ECG Accessory
Heartbeat Sensitivity Calibration Using the ECG Accessory
This is an observational, un-blinded, non-significant risk, non-interventional study designed
 to collect ECG data on at least one subject out of a pool of up to three (3) healthy male
 subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG
 recordings collected by an investigational device for comparison with conventional ECG
 recordings. This data will be used to validate a new device under development.
This is an observational, un-blinded, non-significant risk, non-interventional study designed
 to collect ECG data on at least one subject out of a pool of up to three (3) healthy male
 subjects at one clinical site (Clinical Trials of Texas). If acceptable data is acquired from
 one (1) subject the remaining subjects will not be entered into the study. Three (3) to six
 (6) researchers will record data, but all direct contact with the subject will be done by the
 study coordinator or principal investigator (PI).

 The purpose of this study is to validate a Heartbeat Sensitivity calibration process
 utilizing the Cyberonics ECG Accessory. The non-invasive, passive collection of ECG signals
 from a resting healthy subject will be used to validate the use of the ECG Accessory with the
 Model 201 Programming Wand, Model 250 VNS Programming Software Version 9.0, Model 106
 Generator, and ECG monitor (DRE True ECG-12), as well as the associated Instructions for Use.
 The data generated from this exercise will be used in future clinical trials utilizing this
 device.
Inclusion Criteria:

 -  1. Patients must be 18 years or older, male, and of any race.

 -  2. Patient must be in good general health, fully ambulatory, and able to complete the
 physical aspects of testing requirements.

 -  3. Patient must be willing and able to complete informed consent and HIPAA
 authorization.

 Exclusion Criteria:

 -  1. Subjects with skin abnormalities or conditions that would interfere with ECG
 electrode patch placement or cause subject discomfort with patch placement.

 -  2. Subjects report history of allergies or sensitivity to adhesive tapes or patches.

 -  3. Subjects with major health condition that in the investigator's judgment would
 prevent the subject's successful completion of the study.