Heartbeat Sensitivity Calibration Using the ECG Accessory

Completed

Conditions studied: ECG Comparisons in Normal Healthy Subject

In brief

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.

Key facts

Study ID

NCT01268007

Run by

Cyberonics, Inc.

People needed

1

Starts

2010-12-01

Expected to finish

2010-12-01

Last updated by the study team

2011-01-24

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trials of Texas — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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