Heartbeat Sensitivity Calibration Using the ECG Accessory

NCT01268007 | Completed DMC

• 1 other identifier: E-46
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ECG Comparisons in Normal Healthy Subject

Outcome Measures

Primary Outcomes (1)

• Comparison of ECG measurements

  No specific effectiveness outcomes or calculations are planned for this non-interventional study. The sponsor will use the ECG data collected during this study as a comparison of the subject's actual ECG waveforms obtained through standard ECG connections to the ECG Accessory transmitted heart beat detection signals from the Model 106 Generator to the ECG monitor.

  8 hours

Study Arms (1)

Normal ECG measurements

Observational, un-blinded, non-interventional study designed to collect ECG data on at least one (1) male patient in an outpatient setting.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Normal Healthy male

You may qualify if:

• \. Patients must be 18 years or older, male, and of any race.
• \. Patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements.
• \. Patient must be willing and able to complete informed consent and HIPAA authorization.

You may not qualify if:

• \. Subjects with skin abnormalities or conditions that would interfere with ECG electrode patch placement or cause subject discomfort with patch placement.
• \. Subjects report history of allergies or sensitivity to adhesive tapes or patches.
• \. Subjects with major health condition that in the investigator's judgment would prevent the subject's successful completion of the study.

Sponsors & Collaborators

• Cyberonics, Inc.: lead

Study Sites (1)

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 29, 2010
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 24, 2011

Record last verified: 2010-12

Locations

US (1)